Senior Specialist, Quality Assurance, Sterile Quality - Hybrid

medhunter.de

Base: $106,200.00 - $167,200.00; bonus/equity: eli...
Hybrid
Gmp documentation review and approval
Quality audits and inspections
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 comprehensive benefits package including medical, dental, vision healthcare, retirement benefits, paid holidays, vacation, and sick days.
  • Employees in office-based positions in the U.S. will be working a Hybrid work model consisting of three total days on-site per week, Monday - Thursday, with Friday designated as a remote-working day.

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 audits and inspections
  • Clinical supply manufacturing compliance
  • Deviation and change management
  • Root cause analysis and CAPA
  • Cross-functional team collaboration

Nice-to-have

  • Sterile dosage drug product experience
  • Quality risk management
  • Process improvements
  • Strong interpersonal skills
  • Conflict resolution
  • Technical writing

Key Requirements

  • B.S. in Science or Engineering discipline
  • 5 years pharmaceutical industry experience
  • Understanding of cGMP and EU regulations
  • Ability to work 1st and 2nd shifts
  • Experience with quality audits and EU inspections

Work Rights

Not specified

Tailored Resume

Cover Letter