QA Specialist — Deviation Writing and CAPA | Remote | Contract
A well-known biopharmaceutical company is managing a backlog of open deviations that needs to be addressed. This is a fully remote, short-term contract engagement — approximately 4 to 6 months — supporting a small unit of investigators working in parallel to write, analyze, and close a defined body of quality events. The site operates bioreactors, chromatography, tangential flow filtration, aseptic fill lines, and secondary packaging, and has ISO classified and grade-controlled rooms.
Responsibilities
- Lead end-to-end deviation investigations including initial data review, gap identification, root cause analysis using structured methodologies such as 5 Why, fishbone, and 6M, and final closure in Veeva EQMS
- Review investigation packages to determine whether sufficient supporting data exists to justify conclusions — candidates must be able to recognize when an investigation is incomplete before writing to it
- Work collaboratively within a small remote unit where responsibilities may shift between initiating investigations, writing, and closing depending on workload and stage of each event
Qualifications
- 4 to 7 years of GMP quality assurance experience — biopharma manufacturing background strongly preferred
- Hands‑on experience writing and closing deviations and CAPAs in a regulated commercial manufacturing environment; sterile injectable or aseptic processing exposure is a plus
- Proficiency or familiarity with Veeva EQMS and demonstrated ability to work independently with minimal ramp‑up time
Remote. Must be available to start quickly. One‑and‑done panel interview, 45 minutes. Target pay rate $40 - $45/hr W2.
#J-18808-Ljbffr