QC Chemistry Supervisor:
This role will involve supervising the QC testing of the lab and QC testing of in-process, stability and final drug products.
- Coordinate members of R&D, Manufacturing, and Formulation to provide analytical support.
- Supervise QC Analysts, distributes work load, and monitors progress.
- Supervises and performs product testing where required.
- Reviews test results to ensure compliance with standards; reports any quality anomalies.
- Ensures QC Analysts receive proper training.
- Attends meetings to keep informed of manufacturing priorities.
- Ensures that safety standards are maintained.
- Ensures compliance with applicable cGMP regulations and SOPs.
- Conducts laboratory investigations and generates reports in response to invalid assays, Deviations, OOS/OOT.
- Performs personnel management functions including time sheet submissions, scheduling of vacations, personnel development, and performance evaluations.
- Responsible for all Safety and cGMP activities of associates working in Quality Control Chemistry.
- Writes and revises control test procedures and SOPs.
- Interacts with outside customers or functional peer groups.
- May be responsible for maintaining a specific project.
- Maybe involved in establishing the transfer of methodology from R&D
- Initiates and completes CAPAs and Change Controls in accordance with site procedure
- Maybe required to review and approve Laboratory Investigations
- Act as area SME for Internal and External Inspections
- Perform minimally monthly performance feedback meetings with direct reports.
- Represent area management at leadership meetings as required
- Escalates all performance issues to management and/or HR.
- Minimum of a BA/BSc in Biology, Chemistry or related field.
- 5+ years experience in a lab that is cGMP regulated.
- Supervisory / people management experience in a similar environment.
- Experience with HPLC, UPLC, UV-Spectrophotometry, Densitometry, Compendial chemistry testing techniques including pH, conductivity, appearance and osmolality
- Experience with electronic systems such as LIMS, Empower, Qumas, eDoc, Trackwise
- Knowledge and proficient in the use of Microsoft products including, Excel, Word and Powerpoint.
- Enthusiastic, results and performance driven.
For more information or to apply for this position, please call Ben Forde on 061-512270