Specialist, Quality Systems & Compliance

Merck & Co., Inc.

West Point, PA, US
Base: $87,300.00 - $137,400.00; bonus/equity: elig...
Hybrid
Analytical instrumentation operation
Computerized system 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 requires managing equipment assets, supporting equipment qualification and validation, ensuring compliance with cGMP and internal policies, and collaborating with vendors and cross-functional teams.
  • 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, paid holidays, and vacation.

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: Comprehensive medical, dental, vision, retirement, paid holidays, vacation

Skills & Requirements

Must-have

  • Analytical instrumentation operation
  • Computerized system validation
  • GMP compliance
  • Equipment qualification and calibration
  • Deviation and change control management
  • Vendor and service engineer coordination
  • Project financial management

Nice-to-have

  • Customer focused communication
  • Cross-site collaboration
  • Process improvement
  • Laboratory equipment troubleshooting
  • Team leadership in validation activities
  • Hybrid work model

Key Requirements

  • Bachelor’s degree in biological or chemical science
  • 4+ years validation experience with computerized laboratory systems
  • PMP certification strongly preferred
  • Experience in pharmaceutical or equivalent laboratory environment
  • 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