The role of the QC Laboratory Services Supervisor is to schedule the sampling and testing of raw materials, components, water for injection (WFI), stability samples, in-process and final product testing. The supervisor will develop, coach, and mentor staff members through routine 1-on-1 interactions, IPMP goals, and defined major responsibilities. This position will be a technical subject matter expert (SME) over their functional area, and will provide compliance expertise (e.g. CGMP, CFR, USP, EP, JP).
- Maintains schedules for analytical testing and stability testing that support site manufacturing schedules.
- Organize and oversee equipment release for production support.
- Assist QC Laboratory Services Manager with all day-to-day issues as they arise.
- Oversee CGMP work in lab, including, but not limited to stability testing, finished product, and in-process testing.
- Ensure that all HPLC’s, UV’s, GC etc. are fully calibrated and validated.
- Assist Analytical Services personnel with troubleshooting, etc.
- Coordinate with other Departments such as Formulation, Production, Project Management, and QA to maintain schedules.
- Assist in reviewing QC Batch Records before submission to QA.
- Write and review SOPs and Testing Standards as necessary.
- Assist in writing protocols, reports, etc. as necessary.
- Inform Manager and Director upon observing out of specification results.
- Initiate OOS investigations for Final Product, In-Process, Stability or other CGMP data.
- Trend the Deviation and OOS investigations and batch record turn around.
- Assist with managing Analytical Services related CAPA.
- Participate in investigations and other related studies.
- Provide data review as assigned.
- Train QC Laboratory Services personnel.
- Attend meetings as necessary.
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
III: Education, Experience & Skills
- Bachelor's Degree in Chemistry or closely related field
- Minimum of 5 years of pharmaceutical QC Laboratory work experience with increasing responsibilities
- Minimum of 1 year of supervision / Must have sound knowledge of the functions and expectations of a QC Laboratory in parenteral drug manufacturing and proficiency in Good Manufacturing Practices in a FDA regulated manufacturing facility
- Must have SOP, investigation, protocol, and report writing skills
- Must have good verbal and written communication skills
- Proficiency in MS Office products or comparable word-processing and spreadsheet skills are required
- Must possess skills for general chemistry assays
- Must have an understanding of CGMPs, CFR, USP, EP, JP
- Prior experience with regulatory inspections