The Supervisor, Quality Control, is responsible for managing and providing supervision to the Quality Control Analytical Laboratory, which provides testing support in the area of raw material, finished bulk and product release testing.
Responsibilities include, but are not limited to:
- Supervising resources to ensure that the work performed by the QC laboratory personnel is accurate, timely, efficient and compliant with company policies, safety, quality SOPs, cGMP, GLP regulation and FDA regulation.
- Ensuring that all laboratory personnel use the proper specifications or an associated compendial monograph.
- Distribute work assignments and ensure on time completion and release of raw materials, bulk and third party products.
- Ensure raw material, in-process, bulk product, and finished product testing is scheduled efficiently and in support of production scheduling.
- Ensure that products are released or rejected as appropriate.
- Anticipate problem areas and resolve issues before they impact compliance, product quality, and availability.
- Work with management to streamline operations to ensure that the department operates efficiently.
- Work with the staff for investigating all Out of Specification (OOS) results and properly documenting them.
- Provide technical support for Manufacturing, Quality Assurance and R&D (as applicable) on questionable batches and results.
- Provide regular reports to management regarding products presently in the laboratory along with their testing status and planned completion date.
- Work with peers in developing and implement laboratory documents (SOPs, Specifications, Protocols, Reports, etc.).
- Train chemists as necessary.
- Bachelor’s Degree in Quality, Science or strongly related field.
- Must be familiar with a variety of the field's concepts, practices, and procedures.
- Extensive experience and judgment to plan and accomplish testing goals.
- 7 to 10 years of analytical laboratory experience.
- 2 to 5 years of experience supervising or leading a technical team.
- Experience in chemical and microbiological methods using instrumentation including HPLC, GC, ICP, FTIR/NIR, UPLC/MS, ELISA and micro plate readers, or other chemical or microbiological techniques as required.
- Technical writing experience.
- Ability to read, analyze, and interpret complex documents.
- Proficient with Microsoft Office (including, Word, Excel, Outlook) and familiarity with basic laboratory record-keeping systems.
- Must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds, and occasionally lift and/or move up to 50 pounds.