Remote QA Specialist, Sterile Injectables

Actalent; Hazelwood (MO); Remote; USD 52,000 - 59,000; Full time

Job summary

Actalent is seeking a Quality Assurance Specialist to support sterile injectable programs and oversee CMOs. The role emphasizes batch review, deviations, CAPAs, and continual improvement in a remote-capable environment.

A strong background in quality systems and cGMP is essential for regulatory alignment. The position is contract-based with remote work options, based out of Hazelwood, MO, with a competitive hourly pay range.

Qualifications

• Bachelors degree in a scientific discipline is required.
• Approximately 5+ years of quality experience; 7+ years preferred.
• Experience with Quality Systems, deviations, change controls, CAPAs, and document management.
• Strong knowledge of cGMP for pharmaceutical manufacturing (CFR 210/211 and CFR 820).
• Proficiency with Good Documentation Practices (GDP).
• Experience with batch record review and batch disposition processes.

Responsibilities

• Prepare, review, and approve CMO batch production documentation for compliance.
• Review batch records, address discrepancies, and escalate issues with senior management.
• Prepare disposition documentation and release certifications for compliant product release.

Skills

Quality systems

cGMP knowledge

Batch review

Supplier qualification

Data analysis

Education

Bachelors degree in a scientific discipline

Job description

Actalent is seeking a Quality Assurance Specialist to support sterile injectable programs and oversee CMOs. The role emphasizes batch review, deviations, CAPAs, and continual improvement in a remote-capable environment.

A strong background in quality systems and cGMP is essential for regulatory alignment. The position is contract-based with remote work options, based out of Hazelwood, MO, with a competitive hourly pay range.