Quality Assurance Specialist
2 weeks ago
We are leading the way in gene therapy advancements, providing innovative solutions in a vibrant and expanding field. As a member of our Gene Therapy Division, you will be crucial in enhancing patient care by engaging directly with modified patient cells that are returned as life-saving therapies. This role presents an exciting opportunity for growth due to our ongoing business expansion.
Position Summary: In the role of Quality Control Analyst, you will be a vital contributor to the Quality Control team, facilitating the production of in-process and final product drug lots for our clientele. Your responsibilities will encompass participation in quality assessments for ongoing customer stability studies, ensuring timely and high-quality outcomes to satisfy manufacturing requirements. You will also have the chance to engage in various initiatives, including method transfers, new instrument validations, and method qualifications.
Location: Portsmouth, NH
Compensation and Benefits:
- Competitive base salary ranging from $60,000 to $100,000, commensurate with experience.
- Minimum bonus of 7.5%, with potential for increased percentage based on performance.
- Comprehensive Medical, Dental, and Vision insurance.
- 401(k) plan with company matching.
- 120 hours of paid time off and 12 paid holidays annually.
- Tuition reimbursement program.
- Potential assistance for relocation available.
Work Schedule Options:
- 4x10 hour shifts per week with available options for:
- 7 AM - 5 PM
- 12 PM - 10 PM
- 10 PM - 7 AM
- Availability to work on weekends is required.
Qualifications:
- Minimum of an Associate's degree; Bachelor's degree or higher is preferred.
- 5+ years of quality experience in a GMP setting.
- Experience in the biotechnology or pharmaceutical sectors is preferred but not mandatory.
Key Responsibilities:
- Perform testing on samples for In-Process, Lot Release, and Stability studies.
- Review and interpret assay results to ensure precision and compliance.
- Provide training to other team members on quality control protocols and procedures.
- Document and maintain quality records, including Deviation, CAPA, Change Control, and Test Methods.
- Engage in projects such as method transfers, new instrument qualifications, and method validations.
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