We are seeking a high-caliber QA Investigation Reviewer (Quality Assurance Inspector V) for a high-profile, 18-month contract at our state-of-the-art biopharma manufacturing facility in Andover, MA. Acting as an independent, objective quality authority, you will be responsible for the review, guidance, and formal approval of GMP investigations, deviations, and Out-of-Specification (OOS/OOT) events.
In this critical oversight role, you will partner closely with cross-functional teams-including Manufacturing, Engineering, and Quality Control-to ensure rigorous root-cause analysis and regulatory compliance. This position is vital to maintaining product quality, ensuring patient safety, and driving timely batch disposition in a fast-paced commercial manufacturing environment.
location: Andover, Massachusetts
job type: Contract
salary: $53 - 55 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Investigation Review & Approval: Conduct independent, objective QA reviews and provide formal sign-off on major/critical non-conformances, deviations, OOS, and OOT quality events.
- Root-Cause Analysis (RCA): Partner with cross-functional technical teams (Manufacturing, Engineering, QC) to ensure investigations utilize robust RCA methodologies and clearly identify true root causes rather than symptoms.
- CAPA Oversight: Review and approve Corrective and Preventive Action (CAPA) plans, ensuring they are effective, measurable, and directly address root causes to prevent recurrence.
- Regulatory & Audit Readiness: Ensure all quality records are fully compliant with cGMP regulations, global health authority expectations, and internal site procedures. Provide direct support and present quality records during regulatory inspections and internal audits.
- Documentation Excellence: Ensure technical writing within investigations is concise, data-driven, logically sound, and capable of standing alone under regulatory scrutiny.
- Metrics & Continuous Improvement: Monitor deviation and CAPA cycle-time metrics to support timely batch disposition and identify systemic trends requiring broader site escalation.
qualifications:
Minimum Requirements
- Education: High school diploma or GED required.
- Experience: 8-10+ years of direct experience in Quality Assurance, Quality Systems, or technical manufacturing investigation roles within a cGMP biopharma or pharmaceutical environment.
- Technical Expertise: Demonstrated, hands-on experience authoring or approving complex deviations, OOS investigations, and CAPAs. Deep working knowledge of FDA, EMA, and global cGMP regulations.
- Communication Skills: Exceptional technical writing and communication skills, with a proven ability to distill complex technical events into clear, auditable narratives.
- Education: Bachelor's or Associate's degree in a scientific, engineering, or technical discipline.
- Systems: Direct, proficiency-level experience utilizing modern Electronic Quality Management Systems (eQMS), specifically Veeva Vault QMS or TrackWise.
- Modality: Prior experience with biologics, large-molecule, or commercial bioprocess manufacturing.
skills: Good Manufacturing Practices (GMP), Quality Assurance (QA)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
