Senior Specialist, Quality Assurance, Sterile Quality - Hybrid

Memorialdrivevetclinic

Base: $106,200.00 - $167,200.00; bonus/equity: eli...
Hybrid
Gmp documentation review and approval
Quality assurance systems compliance
Clinical supply batch record audits
The Senior Specialist, Quality Assurance is accountable for ensuring GMP compliance in clinical supply drug product manufacture through documentation review, audits, and collaboration with quality teams

Job Summary

  • The Senior Specialist, Quality Assurance is accountable for ensuring GMP compliance in clinical supply drug product manufacture through documentation review, audits, and collaboration with quality teams.
  • This role requires on-site support of production facilities at least 60% weekly and flexibility to work both first and second shifts after training.
  • The company offers a comprehensive benefits package including medical, dental, vision, retirement plans, paid holidays, and vacation.

Matching Summary

The Senior Specialist, Quality Assurance is accountable for ensuring GMP compliance in clinical supply drug product manufacture through documentation review, audits, and collaboration with quality teams.

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

Skills & Requirements

Must-have

  • GMP documentation review and approval
  • Quality assurance systems compliance
  • Clinical supply batch record audits
  • Root cause analysis and CAPA
  • Cross-functional team collaboration
  • Hybrid work model with onsite presence
  • Shift flexibility for 1st and 2nd shifts

Nice-to-have

  • Sterile dosage drug product experience
  • Quality risk management skills
  • Experience with EU regulatory inspections
  • Strong interpersonal and communication skills
  • Continuous improvement initiatives
  • Technical writing and SOP development

Key Requirements

  • B.S. in Science or Engineering
  • 5 years pharmaceutical industry experience
  • Understanding of cGMP and drug regulations
  • Ability to work 1st and 2nd shifts
  • Experience in quality assurance or related functions

Work Rights

US and Puerto Rico Residents Only

Tailored Resume

Cover Letter