GMP/ISO QA Specialist — Documentation & CAPA

Actalent; Wisconsin; On-site; USD 65,000 - 95,000; Full time

Job summary

Actalent is seeking a Quality Assurance Specialist for an on-site role in Wisconsin. You will ensure quality systems comply with GMP, FDA, and ISO, review batch records, inspect raw materials, manage deviations and CAPAs, and support continuous improvement.

The position also handles shipping release, document control, training coordination, EQMS interactions, and audit support, with a focus on accuracy, collaboration with cross-functional teams, and maintaining comprehensive QA records.

Qualifications

• Bachelor’s degree in science or related field required.
• Experience in pharmaceutical manufacturing or regulated life sciences environment preferred.
• Strong knowledge of GMP, FDA, ISO quality system requirements.
• Experience with batch record review and batch record documentation.

Responsibilities

• Review batch records for accuracy and compliance with GMP/FDA/ISO.
• Inspect and approve incoming raw materials per specifications and documentation.
• Write and manage deviations, investigations, change controls, and CAPAs.
• Perform shipping release procedures to ensure quality and documentation readiness.

Skills

GMP knowledge

FDA/ISO awareness

Batch record review

CAPA & deviations

Document control

Cross-functional collaboration

Education

Bachelor’s degree in science

Tools

EQMS

Job description

Actalent is seeking a Quality Assurance Specialist for an on-site role in Wisconsin. You will ensure quality systems comply with GMP, FDA, and ISO, review batch records, inspect raw materials, manage deviations and CAPAs, and support continuous improvement.

The position also handles shipping release, document control, training coordination, EQMS interactions, and audit support, with a focus on accuracy, collaboration with cross-functional teams, and maintaining comprehensive QA records.