Quality Engineer - Clinical Labeling

PPD (Thermo Fisher) UK

Bohemia, New York, United States
Base: $83,300.00–$125,000.00; bonus: eligible for ...
Cgmp and iso 9001 compliance knowledge
Capa and deviation management experience
Change control and risk assessment skills
This role ensures quality excellence and regulatory compliance across clinical manufacturing operations to support life-changing therapies

Job Summary

  • This role ensures quality excellence and regulatory compliance across clinical manufacturing operations to support life-changing therapies.
  • The position requires leading deviation investigations, managing change controls, and supporting internal and external audits in a GMP environment.
  • Candidates will benefit from a comprehensive total rewards package including medical, dental, vision, 401(k), and paid parental leave.

Matching Summary

This role ensures quality excellence and regulatory compliance across clinical manufacturing operations to support life-changing therapies.

Salary

Base: $83,300.00–$125,000.00; Bonus: Eligible for variable annual bonus; Benefits: Comprehensive Total Rewards package including health and 401(k)

Skills & Requirements

Must-have

  • cGMP and ISO 9001 compliance knowledge
  • CAPA and deviation management experience
  • Change control and risk assessment skills
  • Internal and external auditing capability
  • Validation and qualification protocol support

Nice-to-have

  • ASQ CQE or CQA certification preferred
  • ISPE validation principles familiarity
  • Statistical analysis and quality tools proficiency
  • Cross-functional collaboration abilities
  • Strong problem-solving and root cause analysis

Key Requirements

  • Bachelor's degree with 5+ years experience or Advanced degree with 3+ years
  • Engineering, Life Sciences, Chemistry, or related technical discipline
  • Experience in pharmaceutical, medical device, or biotech QA
  • Must be legally authorized to work in the United States without sponsorship

Work Rights

Must be legally authorized to work in the United States

Tailored Resume

Cover Letter