Quality Assurance Specialist

JCW Group; United States; On-site; USD 55,104 - 61,992; Full time

Job summary

A well-known biopharmaceutical company is seeking a remote QA Specialist for a short-term contract. This role involves leading deviation investigations and writing CAPAs, requiring 4 to 7 years of GMP quality assurance experience. Candidates should have hands-on experience in a regulated commercial environment, ideally with sterile injectables. Proficiency with Veeva EQMS is preferred. The engagement lasts approximately 4 to 6 months, with a target pay rate of $40 to $45 per hour.

Qualifications

• 4 to 7 years of GMP quality assurance experience in biopharma manufacturing.
• Experience writing and closing deviations and CAPAs in a regulated environment.
• Ability to work independently and start quickly with minimal ramp-up time.

Responsibilities

• Lead end-to-end deviation investigations including gap identification and root cause analysis.
• Review investigation packages to assess if supporting data is sufficient.
• Collaborate in a remote unit, shifting responsibilities as needed.

Skills

GMP quality assurance experience

Writing and closing deviations

Root cause analysis

Collaboration in remote teams

Tools

Veeva EQMS

Job description

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.