Quality Control Team Lead - Pharmaceuticals
We are looking for a Quality Control Team Lead (QCTL) that will assign and/or assist QC management in assigning daily or routine functions and responsibilities to QC personnel and ensure that work is performed in a timely manner and adjust responsibilities as needed to ensure timely completion.
Roles and Responsibilities:
- The Quality Control Team Lead (QCTL) on Mid-shift reports to the Quality Control (QC) Management.
- The QCTL will be responsible for implementation of QC management/upper management direction for all activities, documentation and testing of samples submitted to the QC laboratory.
- Is responsible for testing routine QC samples for release and peer review of test result reports.
- The QCTL will assist QC management with establishing and maintaining appropriate Standard Operating Procedures (SOPs) and departmental compliance processes.
- Is responsible for ensuring that personnel are trained on all relevant SOPs and provide such training when required.
- Is responsible for ensuring QC Laboratory instrumentation is properly calibrated and all scheduled and non-scheduled calibrations, qualifications, and preventative maintenance procedures are performed as needed.
- Ensures departmental metrics including sample testing Turn Around Times (TAT's) are monitored and met. Provide updates related to metrics to upper management within a timely manner.
- Will follow Current Good Manufacturing Practices (cGMP) documentation guidelines to record all procedures in a timely fashion. Will follow Standard Operating Procedures (SOP) in all functions executed and report any deviations where necessary.
- Will provide feedback to QC management/upper management for opportunities of improvement of laboratory processes.
- Knowledgeable in all QC routine functions and capable of being relied upon to perform any QC related functions including testing of laboratory samples.
- Expected to independently complete assigned projects from QC management/upper management within expected/established time frames.
- Independently manage inter-departmental projects and be relied upon to communicate well within departments outside of the laboratory.
- Stay current on publications released by USP, FDA and other pertinent regulating bodies to ensure the QC Laboratory complies in the areas of analytical applications, release specifications, and documentation practices.
- Assist in evaluating new testing applications and instrumentation, either developing methods or adopting compendial methods. Aid in transferring these new methods into a QC function for routine use. Ensure at the least, these methods are accurate, precise, and robust for daily use on specific samples.
- Assist in resolving Out of Specification (OOS) results and reviewing/approving Laboratory Investigations in the QC Laboratory in accordance with SOPs.
- Ensures proper training of new laboratory personnel.
- Enforces Good Laboratory Practices (GLP's) with the QC laboratory.
- Maintain a safe work environment and ensures all equipment used in the testing procedures is calibrated and properly maintained.
- Regular attendance is required.
- 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.
- Five or more years of QC laboratory experience in a cGMP facility/laboratory, including specific experience with day-to-day operations and processes of a QC laboratory.
- Effective interpersonal, self-motivation, communication skills and the ability to interact with all levels of personnel are required.
- A Bachelor of Sciences (B.S.) or a Bachelor of Arts (B.A.) degree in Chemistry or a related science is required.
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