Failure Investigation Associate
A biotech manufacturing company in Sunnyvale, CA is hiring a Failure Investigation Associate to support, perform and document investigations to determine root cause of various failures. They will evaluate and recommend corrective actions to guide continuous process improvement.
- Support manufacturing activities for first-line investigations of product or process failures
- Support brainstorming and other root cause analysis techniques
- Execute experiments as part of investigations using product software and good lab practices
- Analyze data associated with experiments
- Continuously document progress during investigations and prepare final reports
- Analyze data to identify trends and areas for investigation
- Support or lead failure investigations associated with nonconforming product
- Support and execute planned deviations as part of production support
Bachelor’s degree in Life Sciences or related discipline
Minimum of 5-8 years of relevant professional experience
Experience in data analysis, physical inspection, executing experiments, root cause analysis techniques and documentation of results
Ability to work independently and cross-functionally to provide effective updates at executive level
Excellent organizational and communication skills (oral and written)
Excellent writing and documentation skills
Experience with statistical analysis and data management for large volume complex data sets
Experience working in a manufacturing environment and/or within manufacturing operations under cGMP, ISO and FDA regulations.
Understanding molecular biology products or molecular diagnostic product utilizing nucleic acid amplification tests including system level relationship between reagents, consumable, and instrument components
Experience with real-time multiplex PCR
Experience with MiniTab analysis software
Experience in clean room or biosafety environment with controlled gowning procedures
Familiarity with microfluidics
For more than forty years, Richmar Associates has connected talented job seekers with Silicon Valley businesses from start-ups to Fortune 500. We specialize in the temporary and direct placement services business. Based in the Silicon Valley, Richmar offers staffing solutions that include temporary, temp-to-hire, payroll service, vendor management and direct placement services to clients in the High-Tech Industry.
Richmar is an Equal Opportunity Employer.