Specialist, Quality Systems & Compliance

leHACK

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

Job Summary

  • The Analytical Metrology & Validation specialist will work as part of the Global Quality Large Molecule Analytical Science and drive a culture of quality and operational excellence across the GQLMAS West Point and North Wales labs.
  • This role involves managing equipment assets, supporting equipment qualification and validation, ensuring compliance with cGMP, and collaborating with vendors and internal teams to maintain laboratory instrumentation.
  • The successful candidate will be eligible for 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 work as part of the Global Quality Large Molecule Analytical Science and drive a culture of quality and operational excellence across the GQLMAS West Point and North Wales labs.

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
  • Computerized system validation
  • Deviation and change control management
  • Calibration and maintenance coordination
  • Project financial management

Nice-to-have

  • Cross-site collaboration
  • Customer focused communication
  • Process improvement initiatives
  • Team leadership in validation activities
  • Up-skilling in facilities support programs
  • Hybrid work environment
  • PMP certification preferred

Key Requirements

  • Bachelor’s degree in biological or chemical science
  • 4+ years validation experience
  • Experience in pharmaceutical or equivalent laboratory
  • PMP certification strongly preferred
  • Financial acumen in budgeting and forecasting
  • Must be US or Puerto Rico resident
  • No visa sponsorship provided

Work Rights

US and Puerto Rico Residents Only

Tailored Resume

Cover Letter