About the role
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.
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