Remote QA Specialist – Pharma & CMO Oversight

Actalent; United States; Remote; USD 52,000 - 59,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Remote work

Job summary

Actalent seeks a Quality Assurance Specialist to support externally manufactured sterile injectable products, overseeing CMOs and ensuring compliant batch release. You will maintain quality systems, manage deviations and CAPAs, and collaborate with external partners to drive continuous improvement across the product portfolio.

The role emphasizes remote work with a strong focus on documentation, audits, and supplier qualification, requiring 5+ years in quality roles and a background in cGMP

Qualifications

• Bachelor's degree in a scientific field required.
• 5+ years in Quality roles, 7+ years preferred.
• Experience with Quality Systems: deviations, change controls, CAPAs, training, supplier qualification, document management.

Responsibilities

• Review CMO documentation for batch production compliance.
• Review batch records and escalate issues to senior management when needed.
• Prepare disposition docs and release certifications for batches.
• Oversee third-party supplier activities and ensure quality expectations are met.
• Monitor CMOs and coordinate quality communications to address supply issues.
• Analyze quality data to identify trends, risks, and improvement opportunities.
• Maintain quality records including deviations, CAPAs, and training records.
• Oversee cold-chain logistics and ensure regulatory compliance.
• Contribute to audit readiness and supplier audits as needed.
• Lead or support QMS-related projects and continuous improvement initiatives.

Skills

Quality Systems

cGMP knowledge

Sterile injectables

Deviations & CAPAs

Supplier qualification

Audits

Documentation

Data analysis

Education

Bachelor's degree in a scientific discipline

Tools

QMS software

Job description

Actalent seeks a Quality Assurance Specialist to support externally manufactured sterile injectable products, overseeing CMOs and ensuring compliant batch release. You will maintain quality systems, manage deviations and CAPAs, and collaborate with external partners to drive continuous improvement across the product portfolio.

The role emphasizes remote work with a strong focus on documentation, audits, and supplier qualification, requiring 5+ years in quality roles and a background in cGMP