Specialist, Quality Systems & Compliance

Newyorkbioconnect

West Point, PA, US
Base: $87,300.00 - $137,400.00; bonus/equity: annu...
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 team to drive a culture of quality and operational excellence across multiple labs

Job Summary

  • The Analytical Metrology & Validation specialist will work as part of the Global Quality Large Molecule Analytical Science team to drive a culture of quality and operational excellence across multiple labs.
  • The successful candidate will be eligible for an annual bonus and long-term incentive and will receive a comprehensive benefits package including medical, dental, vision, retirement, and paid time off.
  • This role requires managing equipment assets, supporting validation of computerized analytical systems, and ensuring compliance with cGMP and regulatory requirements.

Matching Summary

The Analytical Metrology & Validation specialist will work as part of the Global Quality Large Molecule Analytical Science team to drive a culture of quality and operational excellence across multiple labs.

Salary

Base: $87,300.00 - $137,400.00; Bonus/Equity: Annual bonus and long-term incentive eligibility; Benefits: Comprehensive medical, dental, vision, retirement, paid holidays and vacation

Skills & Requirements

Must-have

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

Nice-to-have

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

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
  • US and Puerto Rico residency required

Work Rights

US and Puerto Rico Residents Only

Tailored Resume

Cover Letter