Sr QC Instrument Scientist

About the role

analytical laboratory operations, instrument qualification, and cGMP compliance for a leading medical device/healthcare organization.

Tasks

• Lead analytical instrument qualification and lifecycle management.
• Coordinate preventive maintenance, vendor activities, and equipment onboarding.
• Maintain laboratory inspection readiness and support QA/EHS audits.
• Support laboratory software validation, LIMS integration, and data integrity.
• Coordinate laboratory relocation and pre-/post-move equipment qualification.

Requirements

• 5–8 years of relevant experience
• Hands-on experience with analytical instruments such as HPLC, GC-FID/MS, GPC-MALS, FTIR, LC-MS, or Instron
• Strong knowledge of 21 CFR Part 11 and cGMP compliance
• Experience with instrument qualification, including IQ/OQ/PQ, calibration, preventive maintenance, and troubleshooting
• Hands-on experience with analytical laboratory relocation and equipment requalification
• Knowledge of laboratory software validation, data integrity, and technical documentation
• QC LIMS implementation experience is a plus

Schedule

• 6 Months | Possible Extension amp; Full-Time Conversion
• Onsite
• W2 Only | No C2C/Third-Party

Pay

• $62–$68/hr (negotiable as per the experience)

How to apply

• Send your updated resume by email or contact by phone.
• Interview Process: 2 rounds | Panel interview via Zoom/Microsoft Teams

Location

• San Diego, CA