The Quality Control Specialist will be responsible for the following :
- Perform daily GMP Quality Control laboratory testing activities
- Perform data analysis and result reporting to support product lot release with adherence to turnaround times.
- Support method transfers and method validation testing
- Support generation and revision of documentation, such as SOPs, protocols and reports, deviations, laboratory investigations, CAPAs and change controls.
- Support technical problem solving for issues pertaining to GMP QC activities
- Support product stability programs including execution of stability testing and stability data analysis
- Perform peer review and or technical review of laboratory data and logbooks
- Responsible for reagent inventory and equipment cleaning and maintenance
Key Responsibilities
- Execution of In-process, finished product, and stability samples
- Support method qualifications, technology transfer and method validations
- Author / Revise SOP’s and Test Methods, Deviations, CAPA’s and Change Controls
- Responsible for inventory and instrument / equipment maintenance
Qualifications & Experience
- Bachelor’s degree in molecular biology, biomedical sciences or related specialties
- Minimum of 2 years experience in the pharmaceutical industry working in a GMP quality control laboratory
- Experience with cell culture, aseptic technique, cell-based potency assays, and flow cytometry
- Proficient knowledge of GMP regulations including USP and EP testing requirements
- Intermediate experience conducting time critical testing of in-process and finished product to meet in process manufacturing needs
- Ability to author, review and maintain test methods, qualification protocols, SOPs and reports
- Conduct laboratory investigations, complete deviations, CAPAs and change controls as needed
- Ability and desire to effectively work in an interdisciplinary team environment and to effectively interact at multiple levels within the company to support internal manufacturing capabilities
Desirable
- 3+ years of experience in the pharmaceutical industry within a GMP Quality Control role; experience with cell therapy products is a plus
- Ability to identify and implement continuous improvement projects for lab process efficiencies
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