Quality Assurance Inspector

Payrate: $50.00 - $55.00/hr.


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.


Responsibilities:

• Conduct independent reviews and approvals of GMP investigations.
• Ensure thorough investigation of non-conformances, deviations, OOS/OOTs, and other quality events.
• Maintain compliance with cGMP regulations, site, and global procedures.
• Support product quality, patient safety, and timely batch disposition.
• Collaborate with cross-functional teams such as Manufacturing, Engineering, and QC.
• Provide objective QA oversight during regulatory inspections and audits.

Qualifications:

• High school diploma or GED required; associate or bachelor's degree preferred.
• 10 years of experience in quality assurance or inspection roles.

Desired Skills:

• Experience in Vault QMS is a plus.
• Strong critical thinking and clear written communication skills.

Pay Transparency: The typical base pay for this role across the U.S. is: $50.00 - $55.00 /hour . Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law.


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