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Quality Control Analyst Ii (Wednesday To Saturday, 3Pm - 1Am)
Company | Resilience |
Address | , East Norriton |
Employment type | FULL_TIME |
Salary | $72,000 - $91,500 a year |
Expires | 2023-10-16 |
Posted at | 8 months ago |
Resilience seeks an Analyst II, Quality Control – Product Testing, supporting the Quality Control department. The successful candidate will perform activities for routine testing of manufacturing release and stability samples of gene (viral vector) and cell therapy products.
The QC Analyst II will partner with Manufacturing and QC operations teams to ensure that all required testing is performed, meeting all partner needs in compliance with standard operating procedures and testing methods.
The position will be in our East Norriton, PA facility and will support weekend testing requirements.
Hours:
- 4 x 10 Wednesday to Saturday; 3pm to 1am
Job Responsibilities:
- Qualify equipment related to testing
- Other activities as assigned
- Analyze, document, and report experimental data in accordance with Resilience requirements
- Review data, identify discrepancies, and escalate issues to management
- Author SOPs, methods, protocols, training materials, and reports in alignment with applicable cGMPs, business standards, and intended use
- Document work in accordance with cGMPs, established business processes and applicable SOPs
- Perform method transfer and qualification activities
- Perform routine sample analysis in support of manufacturing release and stability activities
- Participate in method qualification/validation activities as necessary
- Investigate OOS or OOT events and develop/implement preventive and corrective actions
- Sample testing of lentiviral vector and CAR-T products using protein-based assays, molecular methods, and cellular assays
- Maintain, calibrate, and operate analytical equipment
Minimum Qualifications:
- Knowledge of general analytical methods
- GLP or GMP experience required
- Experience in mammalian cell culture
- BS in relevant discipline (immunology, cell biology, or related field)
- 2-5 years relevant life science experience
Preferred Qualifications:
- Background in Cell Therapy/Gene Therapy
- Experience in a laboratory environment
- Thrives in matrix environment
- Ability to thrive in ambiguous or complex situations
- Excellent interpersonal, verbal and written communication skills
- Highly motivated and self-directed
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