Quality Assurance Inspector

Quality Assurance Inspector / QA Batch Record Reviewer

Location:

Andover, MA 01810

Duration: 12‑month contract

The main function of a Quality Assurance Inspector is to ensure that products, materials, and processes meet established quality standards and regulatory requirements. A typical Quality Assurance Inspector performs batch record reviews and collaborates with production teams to maintain consistent product quality.

• Conduct batch record review, document review, and perform QA on the floor.
• Collaborate with production and engineering teams to resolve quality issues.
• Ensure compliance with internal procedures and external standards (e.g., ISO, FDA).
• Participate in audits and support continuous improvement initiatives.

• Perform real‑time batch record review during manufacturing.
• Conduct GMP compliance walkthroughs in production suites.
• Collaborate with operators and multiple teams to ensure compliance.
• Support QA activities on the floor, not just desk‑based review.

• Strong attention to detail and analytical thinking.
• Knowledge of quality assurance methodologies and regulatory standards.
• Effective communication and documentation skills.
• Ability to interpret technical drawings and specifications.
• Familiarity with quality management systems and software.
• Ability to gown in and out of manufacturing suites is required.

• Bachelor’s degree in a scientific field preferred.
• 0–2 years of experience in quality assurance or inspection roles.

• Bachelor’s degree in a science field (Biology or Chemistry preferred, but flexible).
• 0–2 years acceptable.
• Prior experience with batch record review is a strong plus.
• GMP experience is critical (must have).
• Ability to work collaboratively with diverse teams and personalities.
• Strong communication skills and adherence to company values.

• Previous QA experience in a manufacturing environment.
• Familiarity with pharmaceutical or biotech operations.

• Collaborative and adaptable.
• Comfortable interacting face‑to‑face with operators.
• Strong attention to detail and compliance mindset.

The United States Government does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non‑merit factor.