QA Specialist, DSM Operations (Days 2-2-3 / 0600-1800)
On-siteHolly Springs, North Carolina, United States
Job Summary
Provide QA oversight and support for Drug Substance Manufacturing operations, including batch and solution lot record reviews via the Quality Review Management tool. Execute real-time event triage, immediate response to deviations, area changeovers, and work order oversight while ensuring department objectives align with KPIs. Develop QA documentation, procedures, and processes for operational readiness within this cGMP regulated facility. Contribute to efficiency improvement initiatives with other sites and partner with global peers to support 24/7 manufacturing. Works a 12-hour shift on a 2-2-3 cadence from 0600-1800. Join FUJIFILM Biotechnologies in Holly Springs, North Carolina, as we build North America's largest end-to-end CDMO biopharmaceutical manufacturing facility.
Required Qualifications
- BS/BA in Life Sciences or Engineering or equivalent
- Masters in Life Sciences or Engineering or equivalent
- 2+ years of relevant experience
- 0 years' relevant experience
- 1-3 years' experience in a GMP environment
- Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility
- Understanding of GAMP5, Data Integrity, and application of 21 CFR Part 820 and Part 11
- Understanding of cell culture, upstream processes, large scale recovery and/or downstream processes
- Ability to discern audible cues
- Ability to stand for prolonged periods of time, up to 30 minutes
- Ability to sit for prolonged periods of time, up to 120 minutes
- Ability to conduct activities using repetitive motions that include writs, hands and/or fingers
- Ability to conduct work that includes moving objects up to 10 pounds
- Must be flexible to support 24/7 manufacturing facility
- Works a 12-hour shift on 2-2-3 cadence, 0600-1800
- Occasional opportunity for International and/or Domestic travel
Desired Qualifications
- 2+ years of experience in GMP Quality Assurance and/or similar role
- Experience and working knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software
- Training and/or familiarity with Quality Risk Management principles
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