Senior Specialist, Quality Assurance, Sterile Quality - Hybrid

microsatsystems.biz

Base: $106,200.00 - $167,200.00; bonus/equity: eli...
Hybrid
Gmp documentation review and approval
Quality audits and compliance
Clinical supply manufacturing support
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 hybrid work model with on-site support of production facility and staff at least 60% weekly and requires flexibility to work first and second shifts.
  • The successful candidate will be eligible for an annual bonus and long-term incentives, and the company provides a comprehensive benefits package including medical, dental, vision, retirement, and paid time off.

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 compliance
  • Clinical supply manufacturing support
  • Root cause analysis and CAPA
  • Cross-functional team collaboration
  • SOP development and enforcement

Nice-to-have

  • Sterile dosage drug product experience
  • Quality risk management
  • Process improvements
  • Conflict resolution skills
  • Adaptability and flexibility
  • Strong interpersonal communication

Key Requirements

  • B.S. in Science or Engineering discipline
  • 5 years pharmaceutical industry experience
  • Knowledge of cGMP and EU regulations
  • Ability to work first and second shifts
  • Experience in quality assurance or related roles

Work Rights

Not specified

Tailored Resume

Cover Letter