Job Title: Quality Assurance Inspector - V
Location: Andover, MA
Type: Contract
Compensation: $48-$53.99
Contractor Work Model: Onsite – onsite
Hours: 40.0

Overview
Leading pharmaceutical company looking for an experienced Quality Assurance Inspector V. Ideal candidates should have 10 years of experience in quality assurance, GMP investigation review, or inspection-related roles within a regulated manufacturing environment.

Responsibilities

• Independently review and approve GMP investigations, including deviations, non-conformances, OOS/OOT events, and related quality records.
• Ensure investigations are thorough, scientifically sound, and compliant with cGMP regulations, site procedures, and global quality standards.
• Evaluate root cause analyses, corrective and preventive actions (CAPAs), and effectiveness checks for accuracy and completeness.
• Provide objective QA oversight and guidance to cross-functional teams including Manufacturing, Engineering, and QC.
• Support timely batch disposition activities by ensuring quality events are resolved within established timelines.
• Identify compliance risks, investigation gaps, and documentation deficiencies, and drive appropriate resolution actions.
• Participate in internal audits, regulatory inspections, and quality readiness activities as needed.
• Maintain accurate and compliant documentation within electronic quality management systems, including Vault QMS when applicable.

• High school diploma or GED required; associate or bachelor’s degree preferred.
• Minimum of 10 years of experience in quality assurance, GMP investigation review, or inspection-related roles within a regulated manufacturing environment.
• Strong working knowledge of cGMP regulations and quality systems in the pharmaceutical or biopharma industry.
• Experience reviewing deviations, non-conformances, OOS/OOT investigations, and CAPA documentation.
• Ability to conduct detailed, independent reviews with strong critical thinking and analytical skills.
• Strong written documentation and technical communication skills.
• Experience collaborating with cross-functional teams in a manufacturing environment.
• Familiarity with electronic quality management systems; experience with Vault QMS preferred.
• Experience supporting regulatory inspections and audit activities preferred.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Ref: #558-Scientific