Job Description
Summary: The QA Investigation Reviewer is responsible for the independent review and approval of GMP investigations within the Andover biopharma manufacturing facility. This role ensures non-conformances/deviations, OOS/OOTs, and other quality events are thoroughly investigated, and compliant with cGMP regulations, site and global procedures. The position supports product quality, patient safety, and timely batch disposition while partnering with cross-functional teams including Manufacturing, Engineering, and QC. The ideal candidate demonstrates strong critical thinking, clear written communication, and the ability to provide objective QA oversight, including support during regulatory inspections and audits. Education/Experience: High school diploma or GED required;associate or bachelor s degree preferred 10 years of experience in quality assurance or inspection roles. Experience in Vault QMS a plus.
Numbers & Facts
| Location | Andover, MA |
| Industry | Staffing/Employment Agencies |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | http://www.lancesoft.com/ |
About Company
We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.
Skills
- Communication Skillsunmatched
- Cross-Functionalunmatched
- Current Good Manufacturing Practice (cGMP)unmatched
- GMP (Good Manufacturing Practices)unmatched
- High School Diplomaunmatched
- Manufacturingunmatched
- Medical Treatmentunmatched
- Patient Safetyunmatched
- Product Supportunmatched
- Quality Assuranceunmatched
- Quality Controlunmatched
- Regulationsunmatched
- Time Managementunmatched
- Writing Skillsunmatched
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