Senior Specialist, Quality Assurance, Sterile Quality - Hybrid

539

New Jersey, United States
Base: $106,200.00 - $167,200.00; bonus/equity: eli...
Hybrid
Gmp documentation review and approval
Cgmp and sop adherence
Root cause analysis techniques
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.
  • On-site support of production facility & staff (minimum 60% on a weekly basis) is required, with the expectation to work either first or second shift.
  • The salary range for this role is $106,200.00 - $167,200.00, with eligibility for annual bonus and long-term incentive, plus a comprehensive benefits package.

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: Comprehensive package including medical, dental, vision, retirement, paid holidays, vacation, and sick days

Skills & Requirements

Must-have

  • GMP documentation review and approval
  • cGMP and SOP adherence
  • Root cause analysis techniques
  • Regulatory agency inspections preparation
  • Sterile dosage drug product manufacturing

Nice-to-have

  • Collaborative working relationships
  • Continuous improvement initiatives
  • Effective communication with stakeholders
  • Flexibility and awareness of production issues

Key Requirements

  • 5 years of experience in pharmaceutical industry
  • B.S. in Science or Engineering discipline
  • Understanding of cGMPs and related drug regulations
  • Experience in quality control, quality assurance, or manufacturing
  • Ability to manage multiple projects and priorities

Work Rights

Not specified

Tailored Resume

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