Quality Assurance Tech Ii

Par Health

Execute batch record review
Resolve documentation discrepancies
Follow cgmp guidelines
The role is responsible for reviewing manufacturing process documentation to correct record errors and ensure material release

Job Summary

  • The role is responsible for reviewing manufacturing process documentation to correct record errors and ensure material release.
  • Employees must adhere to all internal and basic cGMP guidelines while performing routine GMP walkthroughs with production teams.
  • The position requires maintaining 100% on-time completion of Compliance Wire training and safety requirements.

Matching Summary

The role is responsible for reviewing manufacturing process documentation to correct record errors and ensure material release.

Skills & Requirements

Must-have

  • Execute batch record review
  • Resolve documentation discrepancies
  • Follow cGMP guidelines
  • Perform GMP walkthroughs
  • Maintain safety training completion

Nice-to-have

  • Cross-functional team collaboration
  • High level written communication skills
  • Quick issue identification and resolution
  • Ability to read complex calculations
  • Build relationships with partners

Key Requirements

  • HS Diploma required; Associates or Bachelor's preferred
  • Minimum 1-3 years document review experience in cGMP environment
  • Proficiency in MS Word and Excel
  • Knowledge of FDA and cGMP regulations preferred
  • LIMS, BPCS, and TrackWise experience preferred

Work Rights

Not specified

Tailored Resume

Cover Letter