Job Description
Job Summary:
- The QA Investigation Reviewer is responsible for the independent review and approval of GMP investigations within the client facility.
- This role ensures nonconformances/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.
- 5-7 years of experience in quality assurance or inspection roles.
- Experience in Vault QMS a plus.