Senior Specialist, Quality Assurance, Sterile Quality - Hybrid

leHACK

Base: $106,200.00 - $167,200.00; bonus/equity: eli...
Hybrid
Gmp documentation review and approval
Quality assurance systems
Audits 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.
  • They independently perform routine audits of batch documentation, data, information, procedures, equipment and systems, and/or facilities to ensure compliance with SOPs, GMPs and other applicable worldwide regulations and company procedures.
  • The successful candidate will be eligible for annual bonus and long-term incentive, if applicable, and the company offers a comprehensive package of benefits including medical, dental, vision, retirement benefits, paid holidays, vacation, and sick days.

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, vacation, sick days

Skills & Requirements

Must-have

  • GMP documentation review and approval
  • Quality assurance systems
  • Audits compliance
  • Deviation management
  • Clinical supply manufacturing
  • Root cause analysis
  • Hybrid work model

Nice-to-have

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

Key Requirements

  • B.S. in Science or Engineering
  • 5 years pharmaceutical industry experience
  • Understanding of cGMPs and EU regulations
  • Ability to work 1st and 2nd shifts
  • Experience with quality audits and regulatory inspections
  • Hybrid work schedule with onsite presence
  • No visa sponsorship

Work Rights

US and Puerto Rico Residents Only

Tailored Resume

Cover Letter