Senior Specialist, Quality Assurance, Sterile Quality - Hybrid

med-in.at

Base: $106,200.00 - $167,200.00; bonus/equity: eli...
Hybrid
Gmp documentation review and approval
Quality assurance systems
Clinical supply batch record audits
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 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 clinical supply programs.
  • They independently perform routine audits of batch documentation, data, procedures, equipment and systems to ensure compliance with SOPs, GMPs, worldwide regulations and company procedures.
  • The position offers a comprehensive benefits package 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 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
  • Clinical supply batch record audits
  • Good Manufacturing Practices compliance
  • Root cause analysis and CAPA
  • Cross-functional team collaboration
  • Hybrid work model with onsite support

Nice-to-have

  • Sterile dosage drug product manufacturing
  • Quality risk management
  • Process improvements
  • Conflict resolution skills
  • Technical writing
  • Quality audits and EU regulatory inspections
  • Adaptability to shift changes

Key Requirements

  • B.S. in Science or Engineering discipline
  • 5 years pharmaceutical industry experience
  • Knowledge of cGMP and EU regulations
  • Ability to work 1st and 2nd shifts
  • Experience in quality assurance or related functional roles
  • Willingness to work hybrid with minimum 60% onsite
  • No relocation or visa sponsorship

Work Rights

Not specified

Tailored Resume

Cover Letter