Quality Assurance Specialist

2 weeks ago


Portsmouth, Virginia, United States The Hire Method, LLC Full time
Job Overview

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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