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Experienced Quality Assurance Analyst
OneTrustExperienced Analyst in Quality Assurance performing instrument qualification and supporting validation at Johnson & Johnson. Delivering quality assurance in MedTech environment and contributing to continuous improvement efforts.
About the role
Key responsibilities & impact- Perform routine and complex instrument qualification in compliance with laboratory procedures to support the lab and manufacturing
- Develop and revise laboratory Lifecycle Management SOPs.
- Support investigations to properly identify root cause and implement appropriate corrective and preventative actions to prevent reoccurrence.
- Support validation protocols execution.
- Provide hands-on and effective diagnostics/troubleshooting functions
- Provide laboratory support for capital projects concurrently with a dynamic workload based upon site priorities
- Apply functional knowledge of Quality Control standards to review results of quality audits and regulatory inspections, identify quality issues, and provides support corrective action plans
Requirements
What you’ll need- University/bachelor’s degree in Science / Technical discipline.
- Requires 2-4 years of related work experience
- Strong background and knowledge of Laboratory cGMP Environment.
- Prefer experience in medical devices or life science management, quality management or related field (Medical Devices, Pharma, biotechnology, or equivalent).
Benefits
Comp & perks- Inclusive work environment
- Employee health and wellness programs
- Opportunities for professional development
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Instrument QualificationLaboratory Lifecycle ManagementValidation Protocols ExecutionRoot Cause AnalysisCorrective Action Plans
Soft Skills
Effective DiagnosticsProblem Solving