Biopharma QA Specialist - cGMP & Batch Release (Contract)

Actalent; Colorado; On-site; USD 55,000 - 96,000; Full time

Job summary

Actalent is seeking a Quality Assurance Specialist (Contract) to support a state-of-the-art cell and gene therapy facility in Colorado. The role focuses on quality documentation, material release, and collaboration with QA, Manufacturing, and vendors.

You will review batch records, oversee external batch disposition, and contribute to CAPAs and change controls within a cGMP environment. Strong communication and ERP experience required.

Qualifications

• Bachelor’s degree in Biochemistry, Molecular Biology, Immunology, or life science.
• Minimum 5 years in an FDA-regulated industry or equivalent.
• Strong knowledge of quality management systems and pharmaceutical regulations.
• Experience with cGMP biopharmaceutical manufacturing quality processes.
• Experience releasing materials and managing ERP documentation.
• Excellent communication and cross-functional collaboration.

Responsibilities

• Perform quality review of batch records, manufacturing records, and release docs from CMOs.
• Review deviations, investigations, CAPAs, and other quality events affecting release.
• Evaluate docs to support final external batch release in line with cGMP.
• Review incoming GMP materials and ensure they meet specs.
• Support vendor oversight and ensure QA regulatory compliance.
• Author, review, and approve SOPs and controlled documents.
• Collaborate with QA Operations, Supply Chain, Manufacturing and vendors.
• Work with ERP materials management and NetSuite for documentation.
• Support PQ testing and related quality activities as applicable.
• Communicate with vendors to clarify quality requirements and batch disposition.
• Contribute to quality management system elements and risk management.
• Identify opportunities to streamline processes and improve documentation.
• Perform other quality duties as needed.

Skills

FDA-regulated experience

cGMP knowledge

Quality management systems

NetSuite ERP

Vendor management

SOP writing and review

Batch records review

Deviations/CAPAs handling

Cross-functional collaboration

Effective communication

Education

Bachelor’s degree in Biochemistry / Molecular Biology / Immunology / Life Sciences

Tools

NetSuite ERP

Job description

Actalent is seeking a Quality Assurance Specialist (Contract) to support a state-of-the-art cell and gene therapy facility in Colorado. The role focuses on quality documentation, material release, and collaboration with QA, Manufacturing, and vendors.

You will review batch records, oversee external batch disposition, and contribute to CAPAs and change controls within a cGMP environment. Strong communication and ERP experience required.