Batch Record Review Specialist | GMP Quality

Title: Batch Record Review Specialist | GMP Quality

Location: Greater Bedford Area, MA (Onsite)

Employment Type: Contract

Status: Accepting Candidates

About the Role

Join a regulated manufacturing environment supporting critical quality and compliance activities. This role partners closely with Manufacturing and Engineering teams to ensure products and documentation meet cGMP, FDA, and ISO 13485 requirements while supporting batch review and product release operations.

Key Responsibilities

• Review and approve batch records, supplemental logs, and GMP documentation for accuracy and compliance.
• Perform product release activities for finished goods, intermediates, and manufacturing batches.
• Review and approve incoming materials for release into manufacturing operations.
• Provide on-the-floor QA support, including line clearances and in-process quality checks.
• Support quality investigations, nonconformance reporting, and documentation reconciliation.
• Assist with internal, customer, and regulatory audits while maintaining compliance with quality systems.

Qualifications

• Bachelor's degree or equivalent experience in a related field.
• Experience in GMP/cGMP-regulated manufacturing environments.
• Hands-on experience with Batch Record Review and documentation review.
• Knowledge of FDA regulations, ISO 13485, and quality system requirements.
• Experience supporting QA Compliance, product release, or manufacturing quality activities.
• Proficiency with Microsoft Office and electronic documentation systems.

Compensation (MA Pay Transparency):

• Estimated hourly range: $30–$32/hr (W-2).
• Final rate within this range will be based on skills, experience, and interview results.