Senior Specialist, External Capabilities Validation & Compliance (gxp Compliance & Documentation), Pharmaceutical Analysis & Digital Technologies

29

Rahway, NJ, USA
Base: $106,200.00 - $167,200.00; bonus/equity: ann...
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5+ years pharmaceutical industry experience
Gmp documentation and sop management
Experience with audits and inspections
** A leading pharmaceutical company is seeking a Senior Specialist for their GxP Compliance and Documentation team in Rahway, NJ. The role involves managing GMP documentation, leading audits, and ensuring compliance across a global analytical network, requiring a strong background in pharmaceutical testing and quality assurance. **

Job Summary

  • The role is pivotal in driving a culture of quality and operational excellence across a global analytical network.
  • Key responsibilities include managing GMP documentation, leading audit preparation, and supporting inspection responses for the Rahway site.
  • The position offers a competitive salary range of $106,200.00 to $167,200.00 along with comprehensive benefits including medical, dental, vision, and 401(k).

Matching Summary

Match Score: 75

** A leading pharmaceutical company is seeking a Senior Specialist for their GxP Compliance and Documentation team in Rahway, NJ. The role involves managing GMP documentation, leading audits, and ensuring compliance across a global analytical network, requiring a strong background in pharmaceutical testing and quality assurance. **

Salary

Base: $106,200.00 - $167,200.00; Bonus/Equity: Annual bonus and long-term incentive eligible; Benefits: Medical, dental, vision, 401(k), paid holidays, vacation

Skills & Requirements

Must-have

  • 5+ years pharmaceutical industry experience
  • GMP documentation and SOP management
  • Experience with audits and inspections
  • Bachelor's degree in analytical chemistry
  • Data integrity deep dive activities

Nice-to-have

  • Innovative problem solving strategies
  • Cross-functional collaboration skills
  • Knowledge of ICH guidelines and CFR
  • Diversity and inclusion commitment
  • Team leadership experience

Key Requirements

  • Bachelor's degree required
  • Minimum 5 years relevant industry experience
  • Experience supporting laboratory audits and inspections
  • Background in GMP environment
  • US work authorization required

Work Rights

Not specified

Sponsorship: available

Tailored Resume

Cover Letter