Job Description

Job Title : Quality Assurance Inspector - I/QA Batch Record Reviewer

Location : Andover, MA 01810

Duration : 12 Months (Possibility of extension depending upon business requirements and performance)

Pay Rate : $25.95/hour

Summary:

• 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.

Job Responsibilities:

• 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.
• Conduct batch record review, document review and perform QA on the floor responsibilities.
• 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

Skills:

• 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.

Education/Experience:

• Bachelor’s degree in a science field (Biology or Chemistry preferred, but flexible).
• 0–2 years acceptable (entry-level).
• 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.

Nice-to-Haves:

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

Soft Skills:

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

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