Senior QA Specialist (Stability)

We are ‘Advancing tomorrow’s medicines’ and making a real difference to the world in which we live. At Fujifilm Diosynth Biotechnologies, we partner with our clients to deliver recombinant proteins, viral vaccines and gene therapies to patients. As a Contract Development & Manufacturing Organization (CDMO), our focus is to combine technical leadership in cell culture, microbial fermentation and viral vectors with world class GMP manufacturing facilities to advance tomorrow’s medicines.  We seek candidates with proven ability to work independently and collaboratively to achieve optimized strategies, and execution programs with the ultimate goal of delivering products that transform the lives of patients.

The Sr. QA Specialist is an independent contributor for Quality Assurance systems and compliance activities.

Major Activities and Responsibilities:

  • Meet quality and compliance expectations for assigned areas on time, right-fire-time, in compliance with SOPs
  • Contributes from assigned functions as team member
  • Keep current with required site training; Set, monitor and report progress on goals and development activities

Specific Responsibilities:

  • Performs stability study sample set up and removal from chambers, including sample time point pulls and sample submission
  • Responds to chamber alarms and moves materials within retain and stability chambers as required
  • Provides off-hour coverage for the Logistics group as needed
  • Performs sample receipt and tracking.
  • Revises and reviews SOPs and work instructions for material control
  • Serves as SME during audits for Logistics issues, as needed.
  • Other duties as assigned.

Background Requirements

  • BS/BA + 4

Physical Requirements

  • Sitting 50-90%; Standing and walking 10-50%; Lifting up to 25 lbs. (Document Boxes) or 50 lbs. (QA Materials group); Ability to use PPE for Manufacturing, warehouse, and Lab areas

cGMP Capability

  • Follow SOPs, understand and apply principles of Standard Practices behind the SOPs

Work Capability

  • Knows both how and why to do the work with moderate supervision

Problem Solving

  • Identifies and solves problems within SOP framework. Will independently investigate and recommend improvements to management

Decision Making/Conflict Resolution

  • Decisions are governed by SOPs and can assist others in QA peer conflict resolution

Communication Ability

  • Communicates cross functionally with peers and QA management in both oral and written form

Behavioral Expectations

  • Employee consistently promotes positive team attitude and supports business objectives

FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company’s ability to secure an export authorization. FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.

FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.

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