Senior Specialist, Quality Assurance, Sterile Quality - Hybrid

vetshired.us

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 hybrid work model with a minimum of 60% onsite support at the production facility 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 inspections
  • Clinical supply manufacturing compliance
  • Deviation and change management
  • Root cause analysis and CAPA
  • Cross-functional team collaboration
  • Hybrid work model with onsite presence

Nice-to-have

  • Sterile dosage drug product experience
  • Quality risk management
  • Process improvements
  • Strong interpersonal and communication skills
  • Ability to manage multiple projects
  • Conflict resolution
  • Technical writing

Key Requirements

  • B.S. in Science or Engineering discipline
  • 5 years pharmaceutical industry experience
  • Understanding of cGMP and EU regulations
  • Experience in quality assurance or related functional areas
  • Ability to work first and second shifts
  • US and Puerto Rico residency
  • No visa sponsorship available

Work Rights

US and Puerto Rico Residents Only

Tailored Resume

Cover Letter