Sr. QC Specialist
Responsibilities of the Sr. QC Specialist:
- Author, review, and approve GMP documentation (SOPs, protocols, technical reports, test methods, protocols, specifications, and summary reports to support GMP manufacturing).
- Author, review, and approve method transfers and method validations at vendors and internally as appropriate.
- Generate and manage qualification of Reference standard, as needed.
- Manage sample submission for contract manufacturing organizations (CMOs) for testing performed at Contract Testing Organizations (CTOs).
- Review and interpret QC testing data and/or Biologics analytical methods generated by vendor test labs.
- Support vendor OOS/Deviations/Investigations, verifies that data meets current specifications, generates COA(s), and track cycle time metrics, captures related deviations, OOS, CAPAs, atypical results, change controls.
- Identifies and communicates routine technical problems and data and vendor issues within the scope of responsibility.
- Makes and understands basic decisions within scope of responsibility.
- Enters data into a validated data source.
- Prepares protocols/reports as appropriate/necessary.
- Coordinates with departmental peers on project work as appropriate.
Requirements of the Sr. QC Specialist:
- BS Degree in Biology, Chemistry or other Life Sciences.
- Minimum of 6 years of related experience.
- Experience in Quality setting with particular interest in stability studies and data trending.
- Previous experience in Quality Control and/or analytical development is preferred.
- Should have experience in a broad variety of analytical testing techniques, including HPLC, UV, CE, Bioassay, PCR, Gel Electrophoresis, GC-MS, Potency, and biological assays.
Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.