GMP Quality Specialist: CAPA, Audits & Compliance

Actalent; Madison (WI); On-site; USD 40,000 - 56,000; Full time

Benefits offered by this job

Medical, dental & vision coverage

401(k) retirement plan

Life insurance

Job summary

Actalent is seeking an experienced QA Specialist to support quality systems and regulatory requirements in a GMP manufacturing environment in Madison, WI. You will partner with multiple departments to ensure product quality, perform investigations, CAPA, deviations, change controls, and audits.

This onsite role offers competitive benefits and opportunities to influence quality systems and continuous improvement.

Qualifications

• Bachelor's degree in a scientific field related to pharma.
• 5+ years QA experience in GMP-regulated environments.
• Experience managing Deviations, CAPAs, Change Controls, and investigations.
• Familiar with FDA 21 CFR and ICH guidelines.

Responsibilities

• Review and approve SOPs, protocols, and quality documents.
• Support Deviations, CAPA, Change Control, investigations, and complaints.
• Participate in validation activities and quality-improvement projects.
• Assist with internal, supplier, and regulatory audits.
• Support regulatory compliance activities and agency inquiries.
• Track quality metrics across departments.
• Maintain and develop quality system documentation.
• Support transition to electronic quality systems and processes.

Skills

Quality Assurance experience

FDA 21 CFR knowledge

Documentation & writing

MS Office (Excel)

Education

Bachelor's degree in Chemistry/Biology/Biochemistry or related field

Tools

Quality Management System (QMS)

CAPA system

cGMP compliance tools

Job description

Actalent is seeking an experienced QA Specialist to support quality systems and regulatory requirements in a GMP manufacturing environment in Madison, WI. You will partner with multiple departments to ensure product quality, perform investigations, CAPA, deviations, change controls, and audits.

This onsite role offers competitive benefits and opportunities to influence quality systems and continuous improvement.