Specialist, Quality Systems & Compliance

mnssazn.top

West Point, PA, US
Base: $87,300.00 - $137,400.00; bonus/equity: elig...
Hybrid
Analytical instrumentation operation
Equipment qualification and validation
Gmp compliance and regulatory audits
The Analytical Metrology & Validation specialist will drive a culture of quality and operational excellence across multiple labs within the Global Quality Large Molecule Analytical Science department

Job Summary

  • The Analytical Metrology & Validation specialist will drive a culture of quality and operational excellence across multiple labs within the Global Quality Large Molecule Analytical Science department.
  • This role involves managing equipment assets, supporting equipment qualification and validation, and ensuring compliance with cGMP and internal policies during audits.
  • The successful candidate will be eligible for an annual bonus and long-term incentives and will receive a comprehensive benefits package including medical, dental, vision, retirement, and paid time off.

Matching Summary

The Analytical Metrology & Validation specialist will drive a culture of quality and operational excellence across multiple labs within the Global Quality Large Molecule Analytical Science department.

Salary

Base: $87,300.00 - $137,400.00; Bonus/Equity: Eligible for annual bonus and long-term incentive; Benefits: Medical, dental, vision, retirement, paid holidays, vacation, and sick days

Skills & Requirements

Must-have

  • Analytical instrumentation operation
  • Equipment qualification and validation
  • GMP compliance and regulatory audits
  • Computerized system validation
  • Calibration and maintenance coordination
  • Deviation and change control management

Nice-to-have

  • Customer focused communication skills
  • Cross-site collaboration and support
  • Project management and financial acumen
  • Continuous process improvement
  • Laboratory equipment troubleshooting

Key Requirements

  • Bachelor’s degree in biological or chemical science
  • 4+ years validation experience with computerized laboratory systems
  • Experience operating pharmaceutical analytical instrumentation
  • PMP certification strongly preferred
  • Financial management and budgeting experience
  • Must be US or Puerto Rico resident

Work Rights

US and Puerto Rico Residents Only

Tailored Resume

Cover Letter