Pharma QA Specialist - GMP & CAPA Leader

Actalent; Eden Prairie (MN); On-site; USD 34,000 - 41,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Job summary

Actalent in Eden Prairie, MN is seeking a Quality Assurance Specialist to ensure GMP compliance and product quality across manufacturing operations. The role emphasizes on-floor auditing, batch record review, CAPA support, and training of production staff to uphold quality standards.

The position is contract-to-hire, fully onsite, with a pay range of $25.00-$30.00 per hour and benefits eligibility. Applicants should have a science degree and GMP experience.

Qualifications

• Bachelor's degree in Biology, Chemistry, or related field.
• 1+ year GMP-regulated manufacturing experience.
• Experience reviewing batch records and manufacturing documentation.
• Working knowledge of GMP, GDP, FDA regulations, and quality systems.
• Experience with investigations, deviations, non-conformances, OOS events, and CAPA processes.

Responsibilities

• Review batch records and documentation for GMP/GDP compliance.
• Support operations with audits, inspections, and quality oversight.
• Investigate deviations, non-conformances, and OOS; perform root cause analysis and support CAPA.
• Train and mentor production personnel on quality systems and regulatory requirements.
• Approve production activities and releases while ensuring specifications.
• Maintain SOPs and quality docs.
• Identify recurring issues and drive corrective actions and improvement.
• Collaborate with production and warehouse to promote quality culture.
• Support lean manufacturing initiatives such as 5S and waste reduction.

Skills

GMP knowledge

Documentation review

Root cause analysis

Training others

Quality oversight

Education

Bachelor's degree in Biology, Chemistry, or related field

Job description

Actalent in Eden Prairie, MN is seeking a Quality Assurance Specialist to ensure GMP compliance and product quality across manufacturing operations. The role emphasizes on-floor auditing, batch record review, CAPA support, and training of production staff to uphold quality standards.

The position is contract-to-hire, fully onsite, with a pay range of $25.00-$30.00 per hour and benefits eligibility. Applicants should have a science degree and GMP experience.