Overview
Quality Assurance Specialist Jobs in Andover, MA at The Fountain Group
Title: Quality Assurance Specialist
Company: The Fountain Group
Location: Andover, MA
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.
Qualifications:
- Associate or Bachelor’s degree preferred and 5+ years of hands-on experience in quality assurance roles
- QA investigation review experience – Deviations, OOS/OOT, non-conformances in GMP regulated manufacturing setting
- Experience in Vault QMS a plus
