Manufacturing Associate

Responsibilities: Perform detailed reviews of production batch records to ensure compliance with GMP requirements, internal procedures, and documentation standards. Partner with manufacturing personnel, supervisors, and quality leadership to investigate and resolve documentation discrepancies or record exceptions. Evaluate production records, supporting documentation, and associated quality events for completeness and accuracy prior to release activities. Utilize electronic quality and business systems to document reviews, track findings, and support workflow efficiency. Contribute to backlog reduction initiatives while maintaining a high level of accuracy and regulatory compliance across manufacturing operations. Qualifications: Minimum of 1 year of batch record review experience within a pharmaceutical, biotechnology, biologics, or other regulated manufacturing environment; 3-5+ years preferred. Hands-on experience with Quality Management Systems (QMS) and electronic quality platforms; familiarity with multiple systems is highly desirable. Experience using ERP platforms such as SAP, Blue Mountain, or equivalent manufacturing and quality systems. Knowledge of GMP documentation practices, deviation management, exception tracking, and quality review processes. Degree preferred but not required; candidates with strong industry experience and proven batch record review expertise are encouraged to apply. Compensation: Salary Range: $30/hour - $45/hour Schedule: Monday - Friday, 8:00 AM - 5:00 PM with flexibility in working hours Location: Durham, NC Work Arrangement: 100% Onsite Contract Duration: 6 Months Comprehensive Benefits: Medical, Dental, Vision, sick leave if required by law, and 401K Application Details Posting Date: 10/21/2026 Apply By/Closing Date: Open Until Filled