Qa Senior Specialist

39med

Base: $106,200.00 - $167,200.00; bonus/equity: eli...
Hybrid (3 days onsite, 1 day remote)
Cgmp compliance
Regulatory requirements
Quality systems management
39med is seeking a Senior Quality Specialist to ensure compliance with cGMPs and regulatory requirements in manufacturing operations through quality systems and auditing activities. The ideal candidate will have experience in quality assurance within the biologics or pharmaceutical industry, and the position offers a hybrid work model with competitive benefits

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 salary range for this role is $106,200.00 - $167,200.00; Bonus/Equity: Eligible for annual bonus and long-term incentive; Benefits: Comprehensive package including medical, dental, vision, 401(k), paid holidays, vacation, and sick days.

Matching Summary

Match Score: 85

39med is seeking a Senior Quality Specialist to ensure compliance with cGMPs and regulatory requirements in manufacturing operations through quality systems and auditing activities. The ideal candidate will have experience in quality assurance within the biologics or pharmaceutical industry, and the position offers a hybrid work model with competitive benefits.

Salary

Base: $106,200.00 - $167,200.00; Bonus/Equity: Eligible for annual bonus and long-term incentive; Benefits: Comprehensive package of benefits including medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days

Skills & Requirements

Must-have

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

Nice-to-have

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

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

Tailored Resume

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