Remote QA Specialist – Deviation & CAPA Writer (GMP)

JCW Group; United States; Remote; 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

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.