Quality Assurance Specialist

Job Description

We are seeking a QA Associates to support quality operations within a regulated pharmaceutical manufacturing environment. These roles are responsible for ensuring GMP compliance through batch record review, quality documentation oversight, manufacturing support, and quality systems activities.

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QA professionals with 3+ years GMP operations experience are encouraged apply!

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Location: Durham, NC

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Pay: $30-$40/hour depending on experience

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Schedule: M-F 9:00 AM-5:00 PM

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Responsibilities

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• Review batch production records, logbooks, and inspection documentation for accuracy, completeness, and GMP compliance.
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• Ensure documentation follows Good Documentation Practices and data integrity requirements.
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• Support quality review and approval processes for manufacturing activities.
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• Assist with quality investigations, deviations, CAPAs, and documentation updates as needed.
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• Partner with manufacturing personnel to resolve documentation issues and support compliance initiatives.
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• Maintain quality records, tracking logs, and regulatory documentation.
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• Participate in routine manufacturing floor activities to provide QA support and oversight.
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Qualifications

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• Bachelor's degree in Life Sciences, Biology, Chemistry, or a related scientific discipline required.
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• Minimum of 3 years of Quality Assurance experience in a biotechnology, biopharmaceutical, or pharmaceutical manufacturing environment.
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• Experience supporting biologics, gene therapy, cell culture, purification, aseptic processing, or other GMP operations.
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• Experience reviewing batch records and GMP manufacturing documentation.
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***This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!***