Senior Specialist, Quality Assurance, Sterile Quality - Hybrid

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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 regulations.
  • The successful candidate will be eligible for annual bonus and long-term incentive, if applicable, and the company offers a comprehensive package of benefits including medical, dental, vision, retirement, paid holidays, and vacation.

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

Skills & Requirements

Must-have

  • GMP documentation review and approval
  • Quality audits and inspections
  • Clinical supply manufacturing compliance
  • SOP development and enforcement
  • Cross-functional team collaboration
  • Root cause analysis and CAPA

Nice-to-have

  • Sterile dosage drug product experience
  • Quality risk management
  • Process improvements
  • Conflict resolution skills
  • Adaptability to shift changes
  • Strong interpersonal communication

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 inspections

Work Rights

US and Puerto Rico Residents Only

Tailored Resume

Cover Letter