Quality Assurance Specialist

Astrix; Durham (NC); On-site; USD 65,000 - 90,000; Full time

Job summary

Astrix seeks Junior and Senior QA Associates to support GMP-compliant quality operations in a regulated pharmaceutical manufacturing environment in Durham, NC. You will review batch records, ensure data integrity, and support investigations and CAPAs as part of the quality team.

Responsibilities include reviewing production records, ensuring compliant documentation, and assisting with deviations, investigations, and quality system activities while collaborating with manufacturing personnel to

Qualifications

• Bachelor's degree in Life Sciences, Biology, Chemistry, or a related scientific discipline required.
• Minimum of 3 years of Quality Assurance experience in biotechnology, biopharmaceutical, or pharmaceutical manufacturing.
• Experience supporting biologics, gene therapy, cell culture, purification, aseptic processing, or other GMP bioprocessing operations.
• Experience reviewing batch records and GMP manufacturing documentation.

Responsibilities

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

Skills

GMP knowledge

QA experience

Documentation oversight

Biologics exposure

Education

Bachelor's degree in Life Sciences or related

Job description

We are seeking both Junior and Senior 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.

Whether you are an early-career QA professional or a seasoned QA Operations specialist, we encourage candidates with hands-on GMP Quality Assurance experience and exposure to biologics or advanced bioprocessing operations to apply!

Schedule: M-F 9:00 AM-5:00 PM with occasional schedule flexibility

Responsibilities

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

Qualifications

• Bachelor's degree in Life Sciences, Biology, Chemistry, or a related scientific discipline required.
• Minimum of 3 years of Quality Assurance experience in a biotechnology, biopharmaceutical, or pharmaceutical manufacturing environment.
• Experience supporting biologics, gene therapy, cell culture, purification, aseptic processing, or other GMP bioprocessing operations.
• Experience reviewing batch records and GMP manufacturing documentation.