Qa Senior Specialist

medhunter.de

Rahway, New Jersey, US
Base: $106,200.00 - $167,200.00; bonus/equity: ann...
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Cgmp compliance
Regulatory requirements
Quality systems management
** The Senior Quality Specialist position at Medhunter is focused on ensuring compliance with cGMPs and regulatory requirements within manufacturing operations in Rahway, New Jersey. The role involves critical quality oversight, auditing activities, and collaboration with various teams to maintain product compliance and support continuous improvement initiatives. **

Job Summary

  • The Senior Quality Specialist is a key leader in ensuring site-wide compliance with cGMPs and regulatory requirements through robust quality systems and proactive auditing activities.
  • This role provides quality oversight for manufacturing operations, with primary responsibility for managing and executing critical quality systems (e.g., change control, deviation management, and document control), conducting GMP walkthroughs, and supporting internal and external inspections.
  • The successful candidate will be eligible for annual bonus and long-term incentive, if applicable, and a comprehensive package of benefits including medical, dental, vision, and retirement benefits.

Matching Summary

Match Score: 75

** The Senior Quality Specialist position at Medhunter is focused on ensuring compliance with cGMPs and regulatory requirements within manufacturing operations in Rahway, New Jersey. The role involves critical quality oversight, auditing activities, and collaboration with various teams to maintain product compliance and support continuous improvement initiatives. **

Salary

Base: $106,200.00 - $167,200.00; Bonus/Equity: Annual bonus and long-term incentive, if applicable; Benefits: Comprehensive package including medical, dental, vision, 401(k), paid holidays, vacation, and sick days

Skills & Requirements

Must-have

  • cGMP compliance
  • regulatory requirements
  • quality systems management
  • batch record review
  • SOP review and approval
  • deviation management
  • change control

Nice-to-have

  • continuous improvement initiatives
  • team-based environment
  • proactive auditing activities
  • leadership skills
  • risk management

Key Requirements

  • Associate degree with five years experience
  • Bachelor's degree with three years experience
  • Familiarity with GMP documentation review
  • Understanding of cGMPs
  • Understanding of regulatory requirements

Work Rights

Not specified

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