QA Technical 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 QA Technical Specialist will be the subject matter expert for Quality Assurance Systems, compliance activities and stability compliance. Under limited supervision, they will meet quality and compliance requirements in multiple compliance areas.

Major Activities and Responsibilities:

  • Meet quality and compliance expectations for assigned areas on time, right-first-time, and implement assigned compliance improvements
  • Compliance Area SME
  • Keep current with required site training and internal compliance requirements for assigned compliance areas Set, monitor, and report progress on goals and development activities

Specific Responsibilities:

  • Authors, reviews, and approves stability study protocols and reports.
  • Serves as Client QA contact for stability protocols, reports, OOS investigations.
  • Performs stability sample sets and removal from chambers, responds to chamber alarms, and moves materials with retain and stability chambers as required.
  • Reviews analytical stability reports, ensuring compliance to specifications/acceptance criteria.
  • Participates on project teams and collaborates with owners throughout the project lifecycle ensuring stability compliance.
  • Serves as QA contact for QC, Analytical Development and Manufacturing for stability issues.
  • Provides QA stability metrics.
  • Revises and reviews master plans, SOPs, work instructions and training course plans for stability ensuring alignment with qualification documentation.
  • Serves as SME during audits for stability issues, as needed.
  • Other duties as assigned.

Background Requirements

  • BS/BA + 6 years of experience or MS/PhD + 0

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 Std Practices behind the SOPs

Work Capability

  • SME for Specific Internal compliance function with limited supervision

Problem Solving

  • Problem solving skills to identify and solve problems within the SOP and Std Practice Framework. Can lead small QA groups to investigate, recommend improvements to management, and monitor effectiveness of improvements including non-routine issues

Decision Making/Conflict Resolution

  • Can make decisions within the SOP and std practice framework for compliance areas in which they are an SME and can assist others in cross functional peer conflict resolution

Communication Ability

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

Behavioral Expectations

  • Employee demonstrates positive inclusive behaviors, 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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