Quality Assurance Technician II — Batch Records & Compliance

Par Health; St. Louis (MO); On-site; USD 52,000 - 76,000; Full time

Job summary

Par Health is seeking a Quality Assurance Technician II to perform batch record reviews, resolve documentation issues, and support cGMP compliance in a pharmaceutical manufacturing setting. The role emphasizes accurate documentation, timely inspections, and collaboration with manufacturing and QA teams.

Ideal candidates have 1–3 years of review experience, proficient MS Word/Excel skills, and familiarity with FDA regulations and LIMS/BPCS/TrackWise systems.

Qualifications

• HS Diploma required; Associates or Bachelor's degree preferred.
• 1–3 years of document review experience in a cGMP environment preferred.
• Proficiency in MS Word and Excel; knowledge of FDA and cGMP regulations preferred.

Responsibilities

• Execute batch record review and document deficiencies in a computerized system.
• Identify exceptions and report them to production.
• Resolve documentation discrepancies with manufacturing operations to allow material release.
• Perform batch record accountability and Iron Mountain box reconciliation.
• Execute line clearances and assist in inspection of returned goods.
• Follow all internal cGMP guidelines for pharmaceutical operations.
• Perform GMP walkthroughs with production on a routine basis.
• Participate in cross-functional teams to improve review efficiency and support.
• Adhere to safety rules and maintain 100% completion of safety training.
• Maintain 100% on-time Compliance Wire training.

Skills

Attention to Detail

Organizing

Time Management

Written Communication

Documentation Skills

Education

HS Diploma

Associates or Bachelor's degree preferred

Bachelor's degree preferred

Tools

MS Word

MS Excel

LIMS

BPCS

TrackWise

Job description

Par Health is seeking a Quality Assurance Technician II to perform batch record reviews, resolve documentation issues, and support cGMP compliance in a pharmaceutical manufacturing setting. The role emphasizes accurate documentation, timely inspections, and collaboration with manufacturing and QA teams.

Ideal candidates have 1–3 years of review experience, proficient MS Word/Excel skills, and familiarity with FDA regulations and LIMS/BPCS/TrackWise systems.