Senior Specialist, Quality Assurance, Sterile Quality - Hybrid

Vetamc

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.
  • 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 benefits package including medical, dental, vision, retirement, 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 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 and communication skills
  • Adaptability to shift changes
  • Continuous improvement initiatives

Key Requirements

  • B.S. in Science or Engineering
  • 5 years pharmaceutical industry experience
  • Knowledge of cGMP and EU regulations
  • Ability to work 1st and 2nd shifts
  • Experience with quality audits and regulatory inspections
  • Experience in clinical supply or related functional areas

Work Rights

Not specified

Tailored Resume

Cover Letter