Specialist, Quality Systems & Compliance

Nerdgigs

West Point, PA, US
Base: $87,300.00 - $137,400.00; bonus/equity: elig...
Hybrid
Analytical instrumentation operation
Computerized system validation
Gmp compliance and audits
The Analytical Metrology & Validation specialist will drive a culture of quality and operational excellence across multiple laboratory sites supporting GMP and non-GMP environments

Job Summary

  • The Analytical Metrology & Validation specialist will drive a culture of quality and operational excellence across multiple laboratory sites supporting GMP and non-GMP environments.
  • This role involves managing equipment assets, participating in validation and calibration activities, and ensuring compliance with regulatory requirements including cGMP.
  • The successful candidate will be eligible for an annual bonus and long-term incentives and will have access to a comprehensive benefits package including medical, dental, vision, and retirement plans.

Matching Summary

The Analytical Metrology & Validation specialist will drive a culture of quality and operational excellence across multiple laboratory sites supporting GMP and non-GMP environments.

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

Skills & Requirements

Must-have

  • Analytical instrumentation operation
  • Computerized system validation
  • GMP compliance and audits
  • Equipment asset management
  • Deviation and change control management
  • Calibration and qualification documentation
  • Project financial management

Nice-to-have

  • Cross-site collaboration
  • Customer focused communication
  • Process improvement initiatives
  • Laboratory equipment troubleshooting
  • Team leadership in validation activities
  • Data integrity and lab modernization

Key Requirements

  • Bachelor’s degree in biological or chemical science
  • 4+ years validation experience with computerized laboratory systems
  • Experience in pharmaceutical or equivalent laboratory instrumentation
  • Project management skills with PMP preferred
  • Financial budgeting and forecasting experience
  • US and Puerto Rico residency required

Work Rights

US and Puerto Rico Residents Only

Tailored Resume

Cover Letter