Pharma QA Specialist — GMP & Compliance Onsite

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

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

PTO / Leave

Job summary

Actalent is seeking a Quality Assurance Specialist to ensure product quality and regulatory compliance on the Eden Prairie, MN manufacturing floor. The role involves auditing the facility, evaluating materials and finished products, and driving continuous improvement with rigorous documentation and training.

Required are a biology/chemistry background and 1+ year in GMP manufacturing, with experience in investigations, CAPA, and quality systems.

Qualifications

• Bachelor's degree in Biology, Chemistry, or a related scientific discipline.
• 1+ year in a GMP-regulated manufacturing environment (pharmaceutical, medical device, etc.).
• Experience reviewing batch records, manufacturing documentation, or production records.
• 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 manufacturing documentation to ensure GMP/GDP compliance.
• Support manufacturing operations through floor presence, audits, inspections, and quality oversight.
• Investigate deviations, non-conformances, and OOS events; perform root cause analysis and support CAPA activities.
• Train and mentor production personnel on quality systems, SOPs, and regulatory requirements.
• Approve production activities and product releases while ensuring specifications are met.
• Maintain and update SOPs, work instructions, controlled forms, and quality documentation.
• Identify recurring quality issues, implement corrective actions, and drive continuous improvement initiatives.
• Partner with production and warehouse teams to promote a strong quality culture and maintain compliance.
• Support lean manufacturing initiatives, including 5S and waste reduction efforts.

Skills

GMP knowledge

Quality systems

Investigations

Education

Bachelor's degree in Biology, Chemistry, or related

Job description

Actalent is seeking a Quality Assurance Specialist to ensure product quality and regulatory compliance on the Eden Prairie, MN manufacturing floor. The role involves auditing the facility, evaluating materials and finished products, and driving continuous improvement with rigorous documentation and training.

Required are a biology/chemistry background and 1+ year in GMP manufacturing, with experience in investigations, CAPA, and quality systems.