NOW HIRING! Quality Control Team Lead in Lancaster, SC
06th November, 2020
Job Type: Direct
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.