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Full-timeDescriptionAs the Associate Manager, Analytical Quality Assurance, you will be responsible to managing the role of QA of QC and analytical development to ensure compliance with cGMP, FDA, Internal Policies, Procedures and Specifications. You wil be responsible for the safe and efficient execution of job duties, and Provide regular monthly updates to senior management regarding the progress and status of cGMP Compliance at the Chantilly site.
JOB DUTIES & RESPONSIBILITIES
- Responsible for reviewing STM'S, Specifications, Change controls and Analytical Investigations.
- Responsible to assign job duties to the analytical data review team according to the priorities.
- Responsible to ensure and perform the data Review of Raw Material, Finished Product, Packaging Materials, In-Process, Finished Product, outside testing data, water testing data, Stability Samples, cleaning validation, swab analysis, equipment calibrations, IQ, OQ, PQ, Method Validations, Verifications of Drug Substance and Drug Product and cleaning methods (Electronic data, Notebooks, logbooks, Reports, and electronic sign off's) and notify Laboratory management or designee for any deviations, Out of Trend, extraneous peaks or out of specification results.
- Responsible for reviewing and approving Certificate of analysis for Raw Materials, Packaging Materials, In-Process, Finished Product, Stability and hold time study samples and make sure that associated investigations are closed prior to approval.
- Responsible for supporting annual product review for analytical data.
- Responsible to prepare/ approve commercial certificate of analysis.
- Responsible for certificate of analysis document control and management.
- Responsible to ensure that the principle of Good Documentation Practices and ALCOA+ are met in the laboratory.
- Responsible for ensuring and performing Data review of Analytical R&D, FDA deficiencies, PDR reports, ANDA submission data related to analytical area.
- Ensure logbook and performance check reviews of all instruments in quality control or analytical laboratory.
- Responsible for ensuring and performing Weekly review of Standard usage logbooks (USP, In-house, secondary, any other pharmacopoeia) and column logbooks.
- Review the data to comply with Laboratory Procedures, Test method, Protocols, GLP, GDP and cGMP and work with Laboratory personnel for any corrections and promote cGMP culture.
- Responsible to ensure the documentation is completed, any discrepancy found during the review shall be corrected before data sign-off.
- Associate manager should be able to multitask, to work with dynamic change of plans, to communicate with cross functional teams, complete the work within the timelines.
- Any additional activity as assigned by the Supervisor.
Management Responsibility
Manage direct reportsResponsibility includes training and developing direct reports to keep abreast of current technology as it relates to cGMP Compliance.
Reports to
Site QA HeadRequirements
Knowledge & Skills
- Knowledge of 21CFR, ICH, USP and other applicable regulatory requirements and standards.
- Manage and host Regulatory inspections.
- Ability to maintain integrity and honesty at all times.
- Ability to communicate and lead with transparency.
- Lead department for optimal performance and set course for future improvements.
- Accountable for performance and results of department.
Minimum Experience & Education Required:
- Requires minimum BA/BS in Pharmacy, Biochemistry, Chemistry or related field with 5 + years of experience in the biotech or pharmaceutical industry.
- Management experience in Quality Control required and MS/MA preferable.
