Quality Operations QA Specialist

Job overview

The Quality Operations QA Specialist role is onsite in Saint Paul, MN; compensation is not specified. The role supports quality assurance activities at a client site, ensuring manufacturing, packaging, and testing operations comply with cGMP and company quality standards. The position exists to maintain quality-system compliance and reliable documentation across operational activities. Through record review, investigations, audit support, and coordination with manufacturing, packaging, and laboratory teams, the specialist helps identify and address quality issues.

What you'll do

• Review batch records, deviations, CAPAs, and change controls
• provide quality support to manufacturing, packaging, and laboratory operations
• ensure compliance with GMP, FDA, and company quality policies
• participate in investigations and root cause analysis
• review and approve SOPs, validation protocols, and reports
• support audits and inspection readiness
• maintain QA documentation and records.

What we're looking for

Skills & competencies

quality assurance

quality operations

qa specialist

cgmp

gmp

fda compliance

batch records

capa

change controls

saint paul mn

katalyst healthcares & life sciences

Work arrangement

• Weekend coverage required

Why this role

The posting notes TrackWise, Veeva, or other electronic quality systems and aseptic or sterile manufacturing experience as nice to have.

About the employer

Katalyst Healthcares & Life Sciences is hiring for this role. Industry: Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). Sector: 54.