Anchen's employees can take satisfaction in knowing they have helped deliver more affordable pharmaceutical products to consumers. Anchen offers a competitive compensation package and excellent benefits. Interested candidates should submit their resume to:
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Anchen Pharmaceuticals, Inc. |
Email:
hr@anchen.com
Fax: 949-639-8195; |
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Summary | A solid understanding of IT Operations and Infrastructure.
Essential Job Functions | This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks.
- Analytical method development and validation for release tests (assay, purity, residual solvents, moisture, dissolution etc)
- Analytical support in evaluating API, as well as for prototype formulations and finished drug products
- Write submission documents, reports, protocols, analytical methods and standard operation procedures
- Assess and introduce new technologies to enhance analytical strength and, contribute to cross-department collaboration proje
Required Knowledge and Skills
- Possess broad analytical chemistry knowledge and strong technical strengths in HPLC, GC, MS, FTIR, UV and other related technologies.
- Previous supervisor/leadership experience.
- Demonstrate capability of quickly learning new technologies and problem solving.
- Knowledgeable of cGMP guidelines, company standard operating procedures, and analytical methods.
- Ability to communicate with project teams and other departments.
Education and Experience
- PhD with lab experience in school setting or M. S. with 3-5 plus years pharmaceutical analysis; or B.S. with 6-10 plus years pharmaceutical analysis.
Physical Requirements and Working Conditions | Incumbents are subject to extended periods of sitting, standing and walking; use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; talk or hear; and taste or smell, looking at monitor, moderate noise levels and some business (international) travel. Work is performed in a FDA and DEA regulated pharmaceutical laboratory environment with risk of exposure to various chemicals.
Summary | Under close supervision, performs a variety of processing duties according to batch record and Standard Operating Procedures (SOP's) in the manufacturing department including, but not limited to, weighing, granulation, compression, blending, encapsulation and coating. This is an entry-level position to the Process Operator class series.
Essential Job Functions: | This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks.
- Reports process or equipment problems to supervisor; performs minor or basic troubleshooting.
- Ensures batch records, equipment log books, and other relevant records are current; performs batch record reconciliation.
- Sets-up and operates equipment for processing operations.
- Cleans and maintains processing rooms and equipment.
- Monitors process and equipment and makes necessary adjustments to maintain batch record specifications.
- Monitors product quality.
- Follows established department SOP’s and batch record instructions.
- Complies with all Company policies and procedures, including safety rules and regulations.
Required Knowledge and Skills
- Current Good Manufacturing Practices (cGMP), SOP’s, cGMP’s, equipment and safety practices.
- Standard Operating Procedures for process rooms and manufacturing area.
- GMP compliance in a regulated work environment.
- Manufacturing processes and equipment procedures.
- Record keeping skills.
- Basic mathematical skills.
- Reading, writing and speaking English.
- Communicating clearly and concisely, both orally and in writing.
- Complying with all Company policies and procedures.
- Complying with all Company safety rules and regulations.
Education and Experience | High School Diploma or equivalent and prefer one (1) year of work experience in a Manufacturing environment.
Physical Requirements and Working Conditions | Incumbents are subject to extended periods of sitting, standing and walking; use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; talk or hear; and taste or smell, looking at monitor, moderate noise levels and some business (international) travel. Work is performed in a cGMP and FDA regulated environment.
Summary | Under close supervision, perform the cleaning and set up of equipments and be familiarized with the processes available in the R&D area.
Essential Job Functions: | This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks.
- Conduct experiments as directed by scientists and/or senior technicians.
- Set up and clean equipment.
- Contribute to process understanding by experienced observation and comparison between experiments.
- Follow instructions of the supervisor.
Required Knowledge and Skills
- Good communication and interpersonal skills.
- Multi-tasked, ability to work independently, efficiently and effectively.
- Comply with all Company safety rules and regulations.
Education and Experience | High School Diploma or Equivalent. Strong scientific or engineering background with experience in pharmaceutical processing preferred.
Physical Requirements and Working Conditions| Incumbents are subject to extended periods of sitting, standing and walking; use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; talk or hear; and taste or smell. Work is performed in a pharmaceutical R&D and operational environment.
Summary | Provide assistance and support to the QA R&D department.
Essential Job Functions: | This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks.
- R&D batch record review for manufacturing and packaging and all related documents, such as manufacturing process study protocol.
- Review of proposed commercial batch record.
- Maintain cGMP compliance, which include cGMP inspection and reporting of compliance status to QA Supervisor.
- Support QA operation in the manufacturing area, which include cleaning, validation sampling, in process testing and sampling,
- sample collection and delivery but not limited to.
Required Knowledge and Skills
- Excellent communication and writing skills.
- Multi-tasked, ability to work independently, efficiently and effectively.
- Demonstrated ability for attention to detail
- Computer literate in MS Office Suite (Word, Excel, Power Point).
- Manufacturing and packaging experience is desirable.
Education and Experience | AA or Bachelor’s Degree and 1-2 years of batch record review experience in a pharmaceutical industry.
Physical Requirements and Working Conditions | Incumbents are subject to extended periods of sitting, standing and walking; use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; talk or hear; and taste or smell, looking at monitor, and moderate noise levels. Work is performed in a cGMP and FDA regulated environment.
Sr. QA Documentation or QA Documentation Supervisor
Summary | Provide support to the QA R&D Department and ensure compliance with cGMP and company policies, procedures and specifications.
Essential Job Functions: | This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks.
- Manage documentation team to support all departments’ document needs.
- Manage electronic and paper documentation system’s operation.
- Review and approval of laboratory document including but not limited to SQARs, test method, protocol, report and investigation.
- Review and approval of R&D manufacturing/packaging batch.
Required Knowledge and Skills
- Excellent communication and writing skills.
- Multi-tasked, ability to work independently, efficiently and effectively.
- Computer literate in MS Office Suite (Word, Excel, Power Point, etc).
Education and Experience| AA or Bachelor’s Degree in a Science related field. 3-5 years experience in Pharmaceutical or relevant industry regulated by FDA. Laboratory and/or manufacturing/packaging experience a plus.
Physical Requirements and Working Conditions | Incumbents are subject to extended periods of sitting, standing and walking; use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; talk or hear; and taste or smell, looking at monitor, and moderate noise levels. Work is performed in a cGMP and FDA regulated environment
Summary | Under supervision, assist in the documentation commercial activities for Quality Assurance Documentation Department.
Essential Job Functions: | This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks.
- Issuance of commercial manufacturing/packaging batch records, forms, logbooks, and other controlled documents to commercial operations in adherence to SOP’s, Company Policies and cGMP.
- Maintain accurate and secure document filing system (master, executed and history files, binder, logbook, etc).
- Training system coordinator for the department.
- Write and revise SOP’s, forms and other relevant QA documents.
- Notify supervisor of any variants to issuance, review of batch records, raw materials and issuance or non-conforming incidents.
- Carry out responsibilities under supervision and in accordance with the organization’s policies, procedures, and state, federal and local laws.
- Distribute revised SOP’s and forms to corresponding QA SOP binder.
- Input data into electronic spreadsheet for Annual Product Review. Order supplies for the department as needed.
- Order supplies for the department as needed.
Required Knowledge and Skills
- Excellent communication and writing skills.
- Multi-tasked, ability to work independently, efficiently and effectively.
- Excellent organizational skills and be detail oriented.
- Computer literate in MS Office Suite (Word, Excel, Power Point).
Education and Experience | High School Diploma or Equivalent. Experience in cGMP or pharmaceutical industry is a plus.
Physical Requirements and Working Conditions | Incumbents are subject to extended periods of sitting, standing and walking, vision to monitor and moderate noise levels. Work is performed in an office environment.
Summary | Support engineering and IT compliance system implementation and ongoing quality activities. Support manufacturing, packaging, IT and lab instrument/software validation activities.
Essential Job Functions: | This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks.
- Review MVP, VPP, URS, FRS, DS, TM, IOPQ, final reports and technical documents related to equipment, facility utility, cleaning and software validation. Prepared qualification/validation documents if necessary.
- Review SOPs related to equipment operation, cleaning, and maintenance. Review documents related to maintenance and calibration.
- Perform investigation and provide proper solution for quality issues related to qualification/validation.
- Assist Quality Management in change control related to equipment, facility, utility, and computerized system.
- Collaborate with IT, manufacturing, and analytical laboratory to develop, implement, and maintain compliance system for computerized systems.
- Maintain quality management computerized system and perform training.
- Assist Quality Management in developing, implementing, and maintaining quality statistical system.
- Participate in internal and external audits.
- Interface effectively with management personnel in QA, QC, R&D, engineering, calibration, maintenance, manufacturing, regulatory affairs, validation, IT and other technical disciplines.
- Prepare and present technical reports related to quality engineering.
Required Knowledge and Skills
- Good communication and writing skill is required.
- Must be able to handle projects with minimum supervision.
- Must have an excellent understanding of GDP and GMP.
- Understand computer validation life cycle and CFR part 210, 211, and 11 are desired.
- Understand basic statistics is desired.
Education and Experience | Bachelor’s Degree in computer science, engineering, or life sciences. 3+ years experience in pharmaceutical industries, and 2+ years experience in validation.
Physical Requirements and Working Conditions | Incumbents are subject to extended periods of sitting, standing and walking, vision to monitor and moderate noise levels. Work is performed in an office environment.
Summary | A solid understanding of IT Operations and Infrastructure.
Essential Job Functions: | This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks.
- Ability to manage, plan, and direct work of IT projects with guidance from IT management.
- Plan, implement, and audit information technology security activities related to the technical infrastructure.
- Vendor product evaluation and testing, proven skills in problem solving and decision making. Excellent interpersonal, organizational and mentoring skills. Strong communication skills (verbal, written, presentation). This person will have the ability to prioritize, multi-task and maintain flexibility in a fast-paced environment.
- Responsible for taking a design from concept to operation both in terms of network technology and supporting systems
- Develop and maintain standards for network architecture that meet network quality and functionality objectives inclusive of leveraging the existing infrastructure.
Required Knowledge and Skills
- Thorough understanding and strong experience with MPLS, and should be familiar with MPLS Traffic Engineering (TE) as well as VPN Technologies. In depth Knowledge of switching/routing and wireless technology. A sound understanding of QOS (Quality of Service) and Traffic Shaping techniques which will need to be applied to the Enterprise network and Data Centers.
- Experience working in a large Windows environment with Active Directory, LDAP, Group Policy etc.
- Experience with Storage Area Networks
- Experience managing, architecting, or designing enterprise data warehouses
- Experience with Business Intelligence and Data Warehousing tools, practices, and methods a plus
- Experience with Oracle, MS SQL Server
- VMware or Virtualization technology experience a plus
- Document Management and Records Management experience a plus
- Linux systems a plus
- Knowledge of MRP/ERP systems
- Experience with Disaster Recovery Planning a plus
- Certifications in Cisco Networking, MCSE is highly desirable
- Technical writing skills
Education and Experience | Degree Computer Science, MIS, Business or equivalent area of study. 5 years of Networking experience, and 5 years of Project lead role.
Physical Requirements and Working Conditions | Incumbents are subject to extended periods of sitting, standing and walking, vision to monitor and moderate noise levels. Work is performed in an office environment.
Regulatory Affairs Associate II/III
Summary
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Elements of Position: Under supervision and using governmental guidelines/guidances and regulations, prepares, reviews and submits Abbreviated New Drug Applications, amendments, all post-approval submissions such as supplements, annual reports and adverse reaction reports to the Food and Drug Administration. Works with technical groups in the regulatory development of data and supporting documentation needed to be submitted to FDA in support of all submissions. Provides the first line of quality review of submitted documents to maximize assurance that the documents are regulatory, scientific, and technical accuracy and adequately support the Company’s position.
- Impact of Position: The submitted documentation determines and governs the regulatory/manufacturing/analytical parameters of the drug product as well as establishing the critical parameters needed to manage the life-cycle of the drug product. Any delay in approval of these applications will significantly affect the Company’s ability to compete in the market place. The skill, knowledge and experience of the Regulatory Affairs Associate are a key element in minimizing approval delays due to errors in the scientific/regulatory rationale and supporting data.
Essential Job Functions: | This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks.
- Reviews, analyzes, evaluates, critiques, and consolidates relevant documents from other departments for inclusion in submissions to regulatory agencies according to FDA’s guidelines/guidance/regulations. Researches any submission deficiency and works with Manager to prepare responses to additional information and/or testing requested by regulatory authorities. Participates in problem solving activities for assigned projects and helps ensure that quality is built into the documents generated since delays in FDA approval of submitted documents will greatly affect the company’s ability to market the product.
- Assists in the preparation of the draft labeling material (labels, inserts, cartons) for submission with the application. Monitors FDA labeling website to ensure that labeling is current with the FDA approved labeling.
- Ensures compliance with all Company policies and procedures, including safety rules and regulations. Carries out responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.
- Performs related duties as assigned.
Required Knowledge and Skills
- Familiar with current Food and Drug Administration (FDA) regulations, guidelines/guidances and current FDA/Regulatory Affairs submission requirements.
- Knowledge of the pharmaceutical industry and familiarity with the drug development process.
- Business, scientific and personal computer hardware and software applications.
- Business English usage, spelling, grammar and punctuation.
- Responding to routine inquiries from management, employees and regulatory agencies.
- Communicating clearly and concisely, both orally and in writing.
- Operating a personal computer.
- Managing multiple projects, duties and assignments.
- Applying Federal, state and local policies, procedures, laws and regulations.
- Establishing and maintaining cooperative working relationships with others.
Education and Experience | Bachelor of Science Degree from an accredited college or university and one (1) to three (3) years regulatory pharmaceutical work experience is desirable. Factors such as similar pharmaceutical work-related experiences (such as QA and Analytical) will be considered.
Physical Requirements and Working Conditions | Incumbents in this class are subject to extended periods of sitting, standing and walking, vision to monitor and moderate noise levels. Work is performed in an office environment.
Summary | Provide analytical support (e.g. stability study, product release testing) for R&D projects.
Elements of Position | Under supervision, performs stability testing for R&D projects. Other temporary assignment such as supporting product release, raw material testing and cleaning verification might be required.
Impact of Position: | The quality of the stability results generated by R&D chemists is crucial and the results will be used by the firm to determine the Anchen product shelf-life based on the stability results. In addition to acquired analytical skill, all R&D Chemist are required to continuously receive proper training in Good Documentation Practice and cGMP practice in order to keep up with the standard in the current pharmaceutical industry. Any unexpected analytical error may significantly affect the operation of production and product development.
Essential Job Functions: | Responsibilities include, but are not limited to, the following. Additional position-specific tasks might be required.
- Conducts routine stability testing. Typical activities may include buffer/solution preparation, standard preparation, operating analytical instruments, generate and document test results.
- Reports to supervisor immediately regarding OOS results and deviation from established testing procedures. Do not retest samples or re-measure samples on his or her own decision where results are questionable. Identify the error under supervision.
- Performs and complete the assigned tasks efficiently within expected time frame
- Documents analytical data under cGMP and corporate guidelines
- Keeps the training record related to the job functions up to date and make sure one received proper training before performing any tests.
- Provides general laboratory support; such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping
- Maintains the R&D lab a GMP and safe working environment.
- Assists lab group leader for other temporary assignments
Required Knowledge and Skills
- Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
- Ability to communicate (speaking and write) fluently in English
- Hand-on experience in basic wet chemistry techniques
- Capable of operating laboratory equipments and performing testing using techniques such as HPLC, GC, UV, Dissolution, FTIR, pH meter, and TLC is desired
- GMP proficient, attention to details and accurate record keeping. Experience in documenting compliance
- Working knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS
- Proficient computer skills
Education and Experience
- Bachelor of Science Degree in chemistry, biology, biochemistry or equivalent education background is acceptable
- Experience in wet chemistry techniques
- Knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS.
- Produce analytical work with good quality and quantity
- Good verbal and written communications skills.
- Attention to details and accurate record keeping
- Establishing and maintaining cooperative working relationships with others.
Physical Requirements and Working Conditions | Incumbents in this class are subject to extended periods of sitting, standing and walking; use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; talk or hear; and taste or smell, looking at monitor, moderate noise levels and some business (international) travel. Work is performed in a FDA and DEA regulated pharmaceutical laboratory environment.
Summary | Provide analytical support (e.g. stability study, product release testing) for R&D projects
Elements of Position | Under supervision, performs stability testing for R&D projects. Other temporary assignment such as supporting product release, raw material testing and cleaning verification might be required.
Impact of Position: | The quality of the stability results generated by R&D chemists is crucial and the results will be used by the firm to determine the Anchen product shelf-life based on the stability results. In addition to acquired analytical skill, all R&D Chemist are required to continuously receive proper training in Good Documentation Practice and cGMP practice in order to keep up with the standard in the current pharmaceutical industry. Any unexpected analytical error may significantly affect the operation of production and product development.
Essential Job Functions: | Responsibilities include, but are not limited to, the following. Additional position-specific tasks might be required.
- Conducts routine stability testing. Typical activities may include buffer/solution preparation, standard preparation, operating analytical instruments, generate and compile test results and perform trending analysis under supervision.
- Manages time effectively to complete assignments in expected time frame
- Documents analytical data under cGMP and corporate guidelines
- Troubleshoots basic instrument problems under supervision.
- Performs notebook review to ensure accurate documentation if required.
- Alerts to and detect abnormalities occurring during performance of tests and review.
- Keeps the training record related to the job functions up to date and make sure one received proper training before performing any tests.
- Provides general laboratory support; such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping
- Maintains the R&D lab a GMP and safe working environment
- Assists lab group leader for other temporary assignments
- Conducts routine stability testing. Typical activities may include buffer/solution preparation, standard preparation, operating analytical instruments, generate and document test results.
Required Knowledge and Skills
- Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
- Ability to communicate (speaking and write) fluently in English
- Hand-on experience in basic wet chemistry techniques
- Capable of operating laboratory equipments and performing testing using techniques such as HPLC, GC, UV, Dissolution, FTIR, pH meter, and TLC
- GMP proficient, attention to details and accurate record keeping. Experience in documenting compliance
- Working knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS
- Proficient computer skills
Education and Experience
- Bachelor of Science Degree in chemistry, biology, biochemistry or equivalent education background with 2+ years experience in Pharmaceutical Industry is preferred.
- Experience in wet chemistry techniques
- Experience in software such as Waters Empower and Sotax WinSotax.
- Working knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS.
- Produce analytical work with good quality and quantity
- Good verbal and written communications skills.
- Attention to details and accurate record keeping
- Establishing and maintaining cooperative working relationships with others.
Physical Requirements and Working Conditions | Incumbents in this class are subject to extended periods of sitting, standing and walking; use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; talk or hear; and taste or smell, looking at monitor, moderate noise levels and some business (international) travel. Work is performed in a FDA and DEA regulated pharmaceutical laboratory environment.
Summary | Provide support to the Compliance Department and ensure compliance with cGMP and company policies, procedures and specifications.
Essential Job Functions | This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks.
- Manage the corporate customer complaints and coordinate complaints investigations with affected sites for investigation reporting.
- Manage the audit data file for suppliers, service providers, contract laboratory, alliance contract, etc.
- Assist in performing internal audits and CAPA follow up.
- Assist in performing external audits (API suppliers, service providers, contract laboratory, alliance contract, etc.) and follow up.
- Assist during regulatory inspections.
Required Knowledge and Skills
- Excellent communication and writing skills.
- Multi-tasked, ability to work independently or with minimum supervision, efficiently and effectively.
- Computer literate in MS Office Suite (Word, Excel, Power Point, etc).
- Working knowledge of the 21 CFR Part 210 and 211, GDP and GMP.
Education and Experience
- AA or Bachelor’s Degree in Chemistry (preferred). 3-5 years experience in Pharmaceutical or relevant industry regulated by FDA. Laboratory experience a plus. Must be able to travel.
Physical Requirements and Working Conditions | Incumbents are subject to extended periods of sitting, standing and walking; use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; talk or hear; and taste or smell, looking at monitor, moderate noise levels and some business (international) travel. Work is performed in a FDA and DEA regulated pharmaceutical laboratory environment with risk of exposure to various chemicals.
Engineering Administrative Assistant
Summary | The administrative assistant will assist in the day to day operations in the Engineering/Maintenance Department.
Essential Job Functions | This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks.
- PM (Preventive Maintenance) tracking to ensure all PM’s are performed on time. This includes issuing PM schedule and PM forms to mechanics.
- Organize and maintain all PM records and work orders.
- Maintain and administer the PM program and parts inventory.
- Keep track of and maintain engineering training records for all mechanics.
- Process purchasing of equipment and facility related parts and supplies.
Required Knowledge and Skills
- Excellent communication and writing skills.
- Multi-tasked, ability to work independently, efficiently and effectively.
- Excellent organizational skills and be detail oriented.
- Computer literate in MS Office Suite (Word, Excel, Power Point).
Education and Experience
- High School Diploma or Equivalent. 2-3 years of administrative experience in the pharmaceutical or medical device industry preferred. cGMP experience a plus.
Physical Requirements and Working Conditions | Incumbents are subject to extended periods of sitting, standing and walking, vision to monitor and moderate noise levels. Work is performed in an office environment.
Summary | To support the Technical Support group and perform various duties related to pharmaceutical product development and manufacturing unit operations and processes.
Essential Job Functions | This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks.
- To follow written SOPs to perform the daily work in a strictly FDA regulated pharmaceutical industry.
- To properly record the related documentation, such as forms, logbooks, manufacturing / packaging batch record, various protocols, etc.
- To set up, operate, monitor, and adjust different types of the testing and process equipment to keep the process stable and under control.
- To involve and conduct the formulation or process development and assist and troubleshoot formulations for pharmaceutical oral dosage forms.
- To conduct the equipment performance qualification, manufacturing / packaging process validations, and technology transfer for scale up.
- To develop and conduct experimental study plans, protocols, and evaluate and qualify multi-source drug components and other pharmaceutical excipients.
- Perform other duties related to formulation and process development as assigned.
Required Knowledge and Skills
- General knowledge of cGMP practice and requirements in pharmaceutical or related industry is preferred.
- Good communication and writing skills.
- Multi-tasked, ability to work independently, efficiently and effectively.
- Capable of independently following up on projects in order to meet target date.
Education and Experience | High school diploma or equivalent. At least one year of experience on machine or equipment operation in pharmaceutical or related industry is preferred.
Physical Requirements and Working Conditions | Incumbents are subject to extended periods of sitting, standing and walking; use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; talk or hear; and taste or smell, looking at monitor, moderate noise levels and some business (national) travel. Work is performed in a GMP manufacturing environment.
Instrumentation and Calibration Specialist
Summary
- Elements of Position: Under minimum supervision, support QC and R&D laboratories in terms of instruments repair, calibration, and qualification. Assist in training and familiarization of new and existing instruments. Organize all documents that pertain to instruments and reference standards certificate of analysis, service reports, preventive maintenance, calibration, and qualification.
- Impact of Position: This position maintains instruments proper routine operations with compliance to regulations (FDA 21 CFR part 11). Ensure users are familiarized with the usage and operation of new and existing instruments. Troubleshoot chromatographic issues and minimized instruments issues and downtime to increase laboratory efficiency and productivity.
Essential Job Functions | This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks.
- Ensure that all analytical instrumentations are in good working condition, qualified, and calibrated for CGMP compliance and comply with Anchen’s corporate requirements.
- Maintain, repair, calibrate, and qualify complex analytical instrumentations in both QC and R&D laboratories using reference standards or NIST traceable standards with accurate documentation following Anchen’s SOPs and CGMP regulations.
- Ensure instruments calibration/qualification documentations are properly maintained.
- Provide assistance and support for analyst/s in troubleshooting instruments issues and LIR investigations.
- Ensure schedule of calibrated instruments and preventive maintenance are accurately entered in the database.
- Contact and coordinate external service contractors for maintenance, calibration, installation, and qualification of new and existing instruments.
- Write and revise SOPs of new and existing instruments, if needed, for compliance.
- Punctual, communicate well with others, and work with good interpersonal skills.
- Work with minimum supervision while observing Anchen’s safety procedure at all times.
- Perform other related duties.
Required Knowledge and Skills
- Strong knowledge in Analytical Equipment Qualification (AIQ) that includes IQ/OQ/PQ and qualification lifecycle.
- Good understanding of cGMP and FDA requirements (21 CFR part 11).
- Good understanding of pharmaceutical GxPs.
- Familiar with chromatographic data systems and databases.
- Able to repair, calibrate, troubleshoot, and maintain complex analytical laboratory instruments such as HPLC, UV/Vis, GC, Dissolution Testers, and FTIR.
- Understanding standard traceability and measurement uncertainty.
- Operation of computerized instruments with software applications such as Waters Empower and Agilent Chemstation/Chemstore.
- Good verbal and written communication skills.
- Good interpersonal skills.
- Good organization and time management skills.
Education and Experience | Bachelor of Science Degree or related field or equivalent from an accredited college or university is desirable with at least two years pharmaceutical work experience is acceptable. Detailed oriented with excellent problem solving and troubleshooting abilities.
Physical Requirements and Working Conditions | Incumbents in this class are subject to extended periods of sitting, standing and walking, vision to monitor and moderate noise levels, and lifting of up to 45 lbs during instruments installations and relocations. Work is performed mainly in a laboratory environment while observing safety and as per written standard operating procedures.
Summary | Under limited supervision, oversees packaging operations, maintains control of pharmaceutical products at all times and assist Section Leader to ensure appropriate daily operation of the Packaging Department. Provide assistance to Technical Services in validation of Product and packaging equipments/facility. Stage packaging components and Package of finished products according to established procedures.
Essential Job Functions | This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks.
- Carries out responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.
- Verifies process compliance with batch record guidelines; maintains accountability of bulk and bottle product and completes all packaging order paperwork.
- Ensures compliance with all Company Policies and Procedures, including safety rules and regulations.
- Performs related duties as assigned reports process or materials inventory.
- Ensures batch records, equipment log books, and other relevant records are current; performs batch record reconciliation.
- Sets-up and operates equipment for processing operations as required.
- Cleans and maintains processing rooms and equipment as required.
- Monitors product quality.
- Complies with all Company policies and procedures, including safety rules and regulations.
- Follows established department SOP’s and batch record instructions; assist in SOP batch record revisions.
Required Knowledge and Skills
- Record keeping and basic mathematical skills.
- Reading, writing and speaking English.
- Different units of measurement, i.e., milligrams, grams and kilograms.
Education and Experience | High School Diploma or equivalent.
Physical Requirements and Working Conditions | Incumbents are subject to extended periods of sitting, standing and walking; use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; talk or hear; and taste or smell, looking at monitor, moderate noise levels. Work is performed in a cGMP and FDA regulated environment.
Summary | Provide analytical support to R&D projects.
- Elements of Position: Under supervision, validates analytical test methods, writes and reviews test methods, validation protocols and validation reports. Performs routine and non-routine testing for R&D product release, stability study, and method validation.
- Impact of Position: The analytical test methods shall be validated with excellent quality according to cGMP and transfer to QC department within specified timeline. Any inaccurate or insufficient validation and delay in release of samples will delay submission of applications which will significantly affect the Company’s ability to compete in the market place.
Essential Job Functions | Responsibilities include, but are not limited to, the following. Additional position-specific tasks might be required.
- Perform analytical method validations and sample analysis.
- Conduct routine and non-routine laboratory analyses such as finished product testing, stability testing, and manufacturing in-process testing which requires critical levels of accuracy.
- Manage time effectively to complete assignments in expected time frame.
- Document analytical data under cGMP and corporate guidelines.
- Review analytical test methods, lab testing results and notebooks to ensure accurate documentation.
- Provide general laboratory support; such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping.
- Maintain the R&D lab a GMP and safe working environment.
- Assist lab group leader for other temporary assignments.
Required Knowledge and Skills
- Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude.
- Ability to communicate (speaking and write) fluently in English.
- Hand-on experience in basic wet chemistry techniques.
- Capable of operating laboratory equipments and performing testing using techniques such as HPLC, GC, UV, Dissolution, FTIR, pH meter, and TLC.
- GMP proficient, attention to details and accurate record keeping. Experience in documenting compliance.
- Working knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS.
- Proficient computer skills.
Education and Experience
- BS degree in chemistry, biology, biochemistry or equivalent education background with 2-4 years experience in Pharmaceutical Industry or
- MS degree in chemistry, biology, biochemistry or equivalent education background with 1-3 years analytical experience in Pharmaceutical Industry or
- Ph.D. degree in chemistry, biology, biochemistry or equivalent education background with 0-2 years analytical experience in Pharmaceutical Industry in the aspect of at lease one of the following area (raw material, stability, method validation or product release).
Physical Requirements and Working Conditions | Incumbents in this class are subject to extended periods of sitting, standing and walking; use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; talk or hear; and taste or smell, looking at monitor, moderate noise levels and some business (international) travel. Work is performed in an FDA and DEA regulated pharmaceutical laboratory environment.
