GMP Quality Assurance Specialist | CI & Compliance

Actalent; Eau Claire (WI); On-site; USD 44,000 - 50,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) retirement plan

Life Insurance

Disability insurance

Health Spending Account (HSA)

Transportation benefits

Employee Assistance Program

PTO/Vacation/Sick Leave

Job summary

Actalent is seeking a Quality Assurance Specialist to support the production of infant formula in a highly regulated manufacturing environment in Eau Claire, WI. You will partner with production teams to investigate quality deviations, perform root-cause analyses, and drive CAPAs while maintaining GMP compliance and quality records.

You will conduct GMP audits, review batch records, and update SOPs to support continuous improvement.

Qualifications

• Bachelor’s degree in Biology, Microbiology, Food Science, Chemistry, or related field.
• 1+ years of quality experience in a GMP-regulated environment.
• Experience in food, pharmaceutical, biotech, or medical device manufacturing preferred.
• Knowledge of GMPs, quality systems, and regulatory requirements.
• Strong investigation, problem-solving, and technical writing skills.
• Ability to manage multiple priorities in a fast-paced environment.

Responsibilities

• Investigate quality deviations and manufacturing issues.
• Conduct root cause analyses and implement corrective actions.
• Perform GMP audits and manufacturing floor inspections.
• Review batch records and resolve documentation discrepancies.
• Prepare deviation reports and maintain quality records.
• Partner with production teams to support compliance and quality standards.
• Update SOPs and quality documentation as needed.
• Support continuous improvement initiatives across the facility.

Skills

Investigations & root-cause analysis

Technical writing

GMP knowledge

Multi-tasking in fast-paced env

Education

Bachelor’s degree in Biology, Microbiology, Food Science, Chemistry, or related field

Job description

Actalent is seeking a Quality Assurance Specialist to support the production of infant formula in a highly regulated manufacturing environment in Eau Claire, WI. You will partner with production teams to investigate quality deviations, perform root-cause analyses, and drive CAPAs while maintaining GMP compliance and quality records.

You will conduct GMP audits, review batch records, and update SOPs to support continuous improvement.