Quality Associate I - Filling (3rd Shift)

Simtrabps

Bloomington, United States
On-site
Cgmp compliance
Aseptic processing oversight
Regulatory agency requirements
Simtra BioPharma Solutions is seeking a Quality Associate I for their 3rd shift in Bloomington, Indiana. The role focuses on maintaining quality oversight during manufacturing processes in a regulated environment, ensuring compliance with cGMP standards

Job Summary

  • The Quality Associate I maintains quality oversight of manufacturing areas by working closely with manufacturing personnel and performing various checks during manufacturing processes.
  • Responsibilities include in-process review of records, reporting deficiencies, performing quality functions in classified areas, and preparing for internal and external audits.
  • The role emphasizes continuous improvement and contributing to an environment where teamwork, productivity, safety, identity, strength, purity, and quality are reflected in the finished product.

Matching Summary

Match Score: 85

Simtra BioPharma Solutions is seeking a Quality Associate I for their 3rd shift in Bloomington, Indiana. The role focuses on maintaining quality oversight during manufacturing processes in a regulated environment, ensuring compliance with cGMP standards.

Skills & Requirements

Must-have

  • cGMP compliance
  • aseptic processing oversight
  • regulatory agency requirements
  • quality risk assessment
  • Nonconformance Report authoring

Nice-to-have

  • continuous process improvement
  • teamwork and collaboration
  • patient health impact

Key Requirements

  • Bachelor's degree (science preferred) or Associate's degree with 1+ year GXP experience or no degree with 2+ years GXP experience
  • Proficiency in Microsoft Office Suite
  • Ability to use enterprise software
  • Ability to gown qualify for Grade A/B areas
  • Must wear appropriate PPE

Work Rights

Not specified

Tailored Resume

Cover Letter