GMP QA Specialist — Batch Records & Compliance

Actalent; United States; On-site; USD 55,000 - 80,000; Full time

Job summary

Actalent in the United States seeks a QA Associate to support data review, batch record management, and quality documentation for animal health and nutrition products. You will collaborate with production, QC labs, supply chain, and customer service to ensure cGMP compliance, maintain SOPs, and support continuous improvement in a highly regulated environment.

This role emphasizes attention to detail, strong communication, and proficiency with electronic systems such as Veeva Vault to document

Qualifications

• Bachelor's or Associate's degree in a related field, or at least 12 months QA or GMP experience.
• GMP, pharmaceutical, life science, or highly regulated quality environment experience.
• Strong communication with QC, Supply Chain, Customer Service and stakeholders.
• Strong documentation skills, SOP review, and quality documentation management.
• Proficiency with electronic document systems such as Veeva Vault.
• High attention to detail in a regulated environment.
• Experience with batch record review and maintenance.

Responsibilities

• Support quality systems by organizing, critically reviewing, and presenting information per procedures and cGMP.
• Provide day-to-day quality support for production areas to ensure compliant operations.
• Apply statistical analysis to support quality decisions and data evaluation.
• Write, review, and revise GMP SOPs to maintain compliant documentation.
• Track, maintain, review, and correct manufacturing records (tickets) for disposition.
• Communicate with QC laboratory about test results for batch release.
• Coordinate with Supply Chain to ensure timely release of batch records.
• Approve raw materials by evaluating COAs, printing permits, and tracking vendor information.
• Coordinate with material coordinators on materials received and needed.
• Print and prepare batch manufacturing records and labels.
• Create COAs and AQIS documents, updating certifications and permits as needed.
• Track COA requests and ensure timely delivery of analyses.
• Perform inbound quality analysis and approve packaging materials.
• Monitor temperature records for bulk materials to ensure proper handling.
• Approve bulk material received for companion animal products.
• Manage documents in Veeva Vault for QA/TS-MS review and approval.
• Ensure quality documentation, SOPs, and batch records are accurate and maintained.
• Conduct QA checks and tests such as titration and pH where applicable.
• Identify process/documentation improvements and support optimization efforts.

Skills

Strong communication

Strong documentation

Math skills

Veeva Vault

GMP experience

Education

Bachelor's or Associate's degree

Tools

Veeva Vault

Job description

Actalent in the United States seeks a QA Associate to support data review, batch record management, and quality documentation for animal health and nutrition products. You will collaborate with production, QC labs, supply chain, and customer service to ensure cGMP compliance, maintain SOPs, and support continuous improvement in a highly regulated environment.

This role emphasizes attention to detail, strong communication, and proficiency with electronic systems such as Veeva Vault to document