Supervisor, Quality Control Lab (Biotech)

Job Summary

The Quality Control Lab Supervisor prepares testing schedules based on priorities, provides hands-on training to new hires, supervises daily testing activities to assure adherence to procedures, cGMP, and SOPs applicable to laboratories, conducts laboratory investigations when needed, participates in cross-functional teams to understand priorities, commit and deliver as committed.

Essential Functions

• Schedules testing/review of raw materials, in-process, finished product, and stability samples, complaint samples, samples from process and cleaning validation activities; assignments shall be in writing and a day in advance.
• Drives effective and efficient shop floor supervision enforcing compliance to data integrity, SOPs, specifications, methods, USP, and cGMP through real time verification of records, LNB, log book, chromatograms, sequences, etc. Helps analysts by trouble shooting methods, instrumentation and execution of the tests.
• Initiates OOS/OOAL investigation, participates in investigation activities, and closes in the books when approved, in a timely manner. Prepares reports of investigation, method transfers, method verification/validation where required. Ensures implementation of CAPA, as identified during the investigations.
• Ensures timely testing and release of raw materials, in-process, finished products, stability samples from the lab. Reviews and approves, COA, stability summary reports, investigations, APR trend data, calibrations, qualifications, and other analytical records as needed.
• Initiates change controls for revisions to any controlled document (SOPs, methods, stability protocol,and specification) applicable to quality laboratory.
• Reviews changes in compendial methods for applicable products and notifies management of such changes in order to determine appropriate course of action.
• Has all laboratory personnel complete weekly worksheet, reviews worksheets with respect to schedules, and submits completed worksheets. Involved in day-to-day laboratory testing and help analysts as and when needed.
• Reviews method transfer protocols/reports/vendor qualifications reports/USP monograph evaluation reports/training records. Identifies training needs and provides necessary training to the analysts as and when needed.

Additional Responsibilities

• Participates in analysis as and when required for special projects. When required, summarizes data for in-process testing, testing and release of finished products, and stability data for trending.
• Attends production planning meeting and updates list with delivery dates committed, tracks delivery dates with respect to committed dates. Submits a list containing weekly samples-in and out.

Education

• Bachelors Degree (BA/BS) in Chemistry or related technical field - Required
• Master Degree (MS/MA) in Chemistry or related technical field - Preferred

Work Experience

• 5 years or more Pharmaceutical Laboratory (With Bachelors) - Required
• 1 year or more Supervisory Experience (With Bachelors) - Required
• 3 years or more Pharmaceutical Laboratory (With Masters) - Preferred
• 2 years or more Supervisory Experience (With Masters) - Preferred

Skills and Abilities

• Must be precise and consistent in laboratory data interpretations with respect to USP general chapters and applicable FDA guidance, easily trainable, ready to learn, thorough in reviewing and evaluating laboratory data with respect to established specifications. - Advanced
• Must have a thorough understanding of analytical chemistry and analytical techniques used in a laboratory setting. - Advanced
• Must be able to identify and troubleshoot problems arising during the course of execution of approved methods. - Intermediate
• Must be flexible to adapt to changes in assignment and be ready to accept any work assigned by laboratory management. - Intermediate
• Must be well versed with Microsoft office programs, computer literate, and be able to communicate both verbally and in writing. - Intermediate