Shift: Wed. - Sat. 7:00am - 6:00pm
Essential Functions and Responsibilities
- Performs deviation investigations for all areas within Quality Control
- Perform out of specification investigations with an emphasis on QC analytical assays (flow cytometry, ELISA, and other cell-based assays) and microbiology assays
- Work cross-functionally to create relevant corrective/preventative actions (CAPA).
- Support maintenance of a database in support of QC metrics and KPl's.
- Revise quality documents in support of deviation mitigation and/or CAPAs
- Support programs to improve on-time closure rates for all quality records.
- Other responsibilities as determined.
Required Education, Skills, and Knowledge
- Bachelor's degree in a relevant discipline (biological sciences or equivalent)
- 1-3 years of experience in the biopharmaceutical industry within a cGMP Quality Control role
- Basic knowledge of biological drug development with respect to Quality Control
- Extremely detail-oriented with strong analytical, written, and verbal communication skills
- Demonstrate sense of urgency; ability to recognize time sensitivity
- Flexible and adaptable style with an eagerness to take on challenges
Preferred Education, Skills, and Knowledge
- Experience with cell and/or gene therapy products
- GMP regulated laboratory experience
- Knowledge of investigation writing
Pay Range: $35-38/hr