Senior Specialist, Quality Assurance, Sterile Quality - Hybrid

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Base: $106,200.00 - $167,200.00; bonus/equity: eli...
Hybrid
Gmp documentation review and approval
Quality assurance systems
Clinical supply manufacturing compliance
The Senior Specialist, Quality Assurance is accountable for review and approval of documentation to support Good Manufacturing Practice (GMP) clinical supply drug product manufacture, testing, release and maintenance of our Company’s clinical supply programs

Job Summary

  • The Senior Specialist, Quality Assurance is accountable for review and approval of documentation to support Good Manufacturing Practice (GMP) clinical supply drug product manufacture, testing, release and maintenance of our Company’s clinical supply programs.
  • The position offers a hybrid work model with three days on-site per week and requires willingness to work both first and second shifts after training.
  • The successful candidate will be eligible for an annual bonus and long-term incentive and will receive a comprehensive benefits package including medical, dental, vision, retirement, and paid time off.

Matching Summary

The Senior Specialist, Quality Assurance is accountable for review and approval of documentation to support Good Manufacturing Practice (GMP) clinical supply drug product manufacture, testing, release and maintenance of our Company’s clinical supply programs.

Salary

Base: $106,200.00 - $167,200.00; Bonus/Equity: Eligible for annual bonus and long-term incentive; Benefits: Medical, dental, vision, retirement, paid holidays and vacation

Skills & Requirements

Must-have

  • GMP documentation review and approval
  • Quality assurance systems
  • Clinical supply manufacturing compliance
  • Audit and inspection readiness
  • Root cause analysis and CAPA
  • Hybrid work model
  • Shift flexibility

Nice-to-have

  • Sterile dosage drug product experience
  • Cross-functional collaboration
  • Continuous improvement initiatives
  • Conflict resolution skills
  • Technical writing
  • Quality risk management
  • Process improvements

Key Requirements

  • B.S. in Science or Engineering discipline
  • 5 years pharmaceutical industry experience
  • Understanding of cGMP and EU regulations
  • Experience in quality assurance or related functional areas
  • Ability to work first and second shifts

Work Rights

US and Puerto Rico residents only

Tailored Resume

Cover Letter