Quality Assurance Specialist Ii

Bachem

Base: $71,856 - $98,857 (specialist ii), $79,904 -...
On-site
Gmp manufacturing environment
Cgmp guidance and compliance
Quality management system implementation
The QA Specialist II ensures drug substances comply with FDA and international regulatory requirements for various stages including research and commercial purposes

Job Summary

  • The QA Specialist II ensures drug substances comply with FDA and international regulatory requirements for various stages including research and commercial purposes.
  • The role involves managing GMP documentation, supporting audits, training new hires, and representing QA in process improvement projects.
  • Bachem offers a total rewards package including competitive pay, annual bonuses, comprehensive benefits, 401(k) with employer contribution, and paid time off.

Matching Summary

The QA Specialist II ensures drug substances comply with FDA and international regulatory requirements for various stages including research and commercial purposes.

Salary

Base: $71,856 - $98,857 (Specialist II), $79,904 - $109,868 (Specialist III); Bonus/Equity: Annual performance bonus; Benefits: Medical/Dental/Vision coverage, 401(k) plan with employer contribution, paid vacation and sick days

Skills & Requirements

Must-have

  • GMP manufacturing environment
  • cGMP guidance and compliance
  • Quality Management System implementation
  • Internal auditing experience
  • Document management electronic systems
  • ISO 7 and ISO 8 cleanroom environments
  • Batch record review and verification

Nice-to-have

  • Proficient in Microsoft Office
  • Effective communication skills
  • Problem-solving and troubleshooting
  • Team collaboration
  • Process improvement participation
  • Ability to multitask in fast-paced environment

Key Requirements

  • Bachelor’s degree in science or Associates with experience
  • 3-5 years Quality Assurance and/or Quality Control experience
  • 3-5 years internal auditing experience
  • 3-5 years working in ISO 7 and ISO 8 environments
  • Knowledge of cGMP and FDA regulations
  • Experience with regulatory agencies
  • Ability to review BPRs and chromatograms accurately

Work Rights

Not specified

Tailored Resume

Cover Letter