Title: QC Specialist II
The Quality Control Specialist II must be able to work in a fast-paced atmosphere and has the technical know-how and self-assurance to take on any task that is required to fulfill their job duties. The specialist will have the opportunity to contribute significantly to daily operations as part of a small but valuable QC Analytical team.
The QC Specialist will perform assays on our clients' GMP products and medication components in support of production, product release, and stability studies, in accordance with the Quality Control Standard Operating Procedure and FDA standards.
- Assist with all day-to-day duties and perform routine analysis of in-process, completed product, and stability samples in accordance with laboratory procedures.
- Create Standard Operating Procedures (SOPs), research protocols, and other documents as directed by the supervisor.
- Technical proficiency in analytical methodology (flow cytometry, ELISpot, and cell counting) as well as adherence to GMP and ICH compliance are required.
- Partake in assay transfer, qualification, and validation research.
- Analyze, evaluate, and debug data as needed, and prepare technical reports.
- Plan and collaborate with other departments to ensure that clinical and stability samples are tested continuously and on time.
- Oversee the shipment and testing of analytical samples provided by CTOs.
- Assist supervisor with OOS and non-conformance investigations.
- Maintain and care for laboratory equipment, as well as execute housekeeping duties.
- Complete all training obligations on time.
- Other responsibilities as assigned
- A Bachelor's degree in Biological Sciences, Biotechnology, or a related discipline is required, (a Master's degree preferred).
- At least two years' experience in an aseptic manufacturing environment (cell and gene therapy), preferably in a Quality organization. 1 year of experience with a desired degree is acceptable.
- Understanding of cGMP and FDA regulations.
- Knowledge of cell therapy analytical methodologies (Flow Cytometry and ELISpot are required).
- Previous experience with nonconformances and/or laboratory investigations
- The ability to learn new procedures and suggest recommendations for project execution or assay optimization.
- Ability to work both independently without supervision as well as be part of a team, demonstrating excellent communication and interpersonal skills, is required.
- Strong problem solving and analytical skills with demonstrated ability to manage several projects simultaneously is a must.
- Ability to effectively plan and organize work activities and prioritize task completion adhering to schedules and deadlines.
- Unlimited PTO
- Annual bonus of 10% (Performance based)
- 10,000 stock units
- 25% first year
- Employer paid BlueCrossBlueShield
- Allow Sponsorship
- Short-Term Disability (Parental/Maternity Leave)