QA Investigation Reviewer

SGS Consulting; Boston (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

SGS Consulting seeks a QA Investigation Reviewer to independently review and approve GMP investigations at our Andover biopharma facility. You will ensure investigations of non-conformances, OOS/OOTs, and other quality events are thorough and compliant with cGMP and global procedures, supporting product quality and patient safety.

Collaborate with Manufacturing, Engineering and QC, provide objective QA oversight, and assist during regulatory inspections and audits.

Qualifications

• 10 years of experience in quality assurance or inspection roles is preferred.
• Experience in GMP investigations and QA oversight.
• Vault QMS familiarity is a plus.

Responsibilities

• Independently review and approve GMP investigations within the Andover biopharma facility.
• Ensure investigations of non-conformances, deviations, OOS/OOT, and other quality events are thorough and compliant with cGMP and procedures.
• Support product quality, patient safety, and timely batch disposition; partner with Manufacturing, Engineering and QC.

Skills

Quality assurance experience

GMP investigations experience

Vault QMS familiarity

Education

High school diploma or GED

Associate or Bachelor's degree preferred

Job description

Job Responsibilities:

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.

Skills:

Preferred 10 years of experience in quality assurance or inspection roles. Experience in Vault QMS a plus.

Education/Experience:

Min. High school diploma or GED required, Associate or Bachelor's degree preferred.