On-Site Quality Assurance Specialist – GMP, CAPA

Actalent; Madison (WI); On-site; USD 62,000 - 78,000; Full time

Benefits offered by this job

Medical, Dental and Vision on day 1

401k with company match

Paid time off: 160 hours vacation, 40?

Job summary

Actalent in Madison, WI, is seeking a Quality Assurance Specialist to provide on-site QA support on the production floor within a regulated pharmaceutical manufacturing environment.

You will partner with operations to perform verifications, walk-throughs, and audits, reviewing batch records and quality documentation to ensure compliance and drive improvements. This role involves CAPA and deviation handling, with diverse shift options.

Qualifications

• QA experience in a regulated environment (GMP/FDA/ISO).
• Minimum 2 years in a regulated industry, 5 years preferred.
• Associates Degree required; Bachelor's degree preferred in a science field.
• Experience with batch records, issuance, and review.
• Knowledge of CAPA and deviation management.
• Experience with audits or on-the-floor quality reviews.

Responsibilities

• Spend majority of time on the production floor supporting day-to-day operations and quality oversight.
• Conduct walk-throughs of production areas to verify procedures and identify issues.
• Perform on-site reviews and mini audits to ensure GMP, FDA, and ISO compliance.
• Assist operations with in-process verifications and checks.
• Review batch records and related quality documentation for completeness and compliance.
• Issue batch records as needed and ensure proper control and traceability.
• Identify quality issues and assist in root cause investigations and CAPA.
• Collaborate with cross-functional teams to promote quality culture and continuous improvement.
• Interact with EQMS for document control and CAPA tracking.

Skills

GMP/FDA/ISO experience

Production floor QA

Documentation and batch records

CAPA and deviation management

EQMS familiarity

Strong written/verbal communication

Education

Associates Degree in Science

Bachelors degree preferred in science

Tools

EQMS

Job description

Actalent in Madison, WI, is seeking a Quality Assurance Specialist to provide on-site QA support on the production floor within a regulated pharmaceutical manufacturing environment.

You will partner with operations to perform verifications, walk-throughs, and audits, reviewing batch records and quality documentation to ensure compliance and drive improvements. This role involves CAPA and deviation handling, with diverse shift options.