Quality Control Laboratory Supervisor - Pharmaceuticals
We are looking for a Quality Control Laboratory Supervisor (QCLS) who reports to the Quality Control Management and is responsible for the day to day supervision of QC lab personnel.
- Good understanding of analytical instrumentation like HPLC, GC, ICP-MS, ICP-OES, etc
- Responsible for managing work load to ensure the flow of samples and timeliness of results in an appropriate manner to support the needs of Manufacturing
- Stay current on publications released by USP, FDA and other pertinent regulating bodies to ensure the Quality Control Laboratory complies in the area of analytical applications, release specifications, and documentation practices.
- Assist QC Management in compliance audits as they pertain to the Quality Control Laboratory, and assist with developing strategies when addressing audit findings.
- Initiate/assist and review sourcing, material, and finished product specifications.
- Assist laboratory personnel in resolving Out of Specification (OOS) and Out of Trent (OOT) results in the laboratory. Aid in determining re-sampling or retesting procedures that are scientifically sound in efforts to determine the cause of the OOS or OOT and implement corrective actions when necessary. Review and sign off on OOS reports and review and sign off on Certificates of analysis and other laboratory reports.
- May serve as the Chemical Hygiene Office and lead safety resource for the Quality Control Laboratory, which involves: ensuring the analysts are working in a safe manner; ensuring that hazardous waste is stored, handled, and disposed of in accordance to state and federal regulations; and understanding and signing waste manifests. Undergo annual training as appropriate to suffice regulating bodies, and work with the Safety Manager in addressing laboratory hazards.
- Oversee and review stability and release testing on raw materials and finished products are performed by laboratory personnel or contract laboratories. Ensure the most current Standard Operating Procedures (SOP's) and in house test methods and/or compendial methods are being followed.
- Follow current Good Manufacturing Practice (cGMP) documentation guidelines to record all procedures or other records in a timely fashion.
- Maintain a safe working environment and ensure that all equipment used in testing procedures in calibrated and properly maintained.
- Perform other assigned duties as may be required in meeting company objectives
- Communicate effectively with other departments within the organization and function within a team environment.
- Prior Supervisory experience including three years of laboratory experience in a cGmp facility is required. Experience with the proper operations of laboratory instrumentation, trouble shooting, and the generation and revision of SOP's and test methods.
- Effective interpersonal, self-motivation skills and the ability to interact with all levels of personnel.
Education and Experience:
- Bachelor of Sciences (B.S.) or Bachelor of Arts (BA) degree in Chemistry or a related science.
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