Laboratory Quality Assurance Specialist
1 week ago
Company Overview
We are a leading life science organization with a strong presence in the pharmaceutical industry. Our company is committed to delivering high-quality products and services that meet the highest standards of quality and regulatory compliance.
About the Role
We are seeking an experienced QC Laboratory Technician to join our Incoming Quality team. The successful candidate will be responsible for supporting the Incoming Quality team in the areas of sample management, primary pack inspection, cleaning analysis, movement of materials across the company network, system transactions, and inspection of primary packaging.
Duties and Responsibilities
- Support the Incoming Quality team in sample management, primary pack inspection, cleaning analysis, and movement of materials across the company network.
- Perform system transactions including movement and shipping of samples across QC labs within the network.
- Inspect primary packaging and ensure compliance with GMP and GxP standards.
- Participate in writing, revising, and rolling out accurate operational procedures, training materials, and maintenance procedures for various Quality systems.
- Review, approve, and trend test results where applicable.
- Peer review other analysts' documentation to ensure QC Right First Time KPIs are achieved.
- Participate in QC daily meetings and ensure effective communication of testing progress, deviations, etc.
- Complete all documentation in compliance with GMP and GxP standards.
- Provide support with audit/inspection requirements to ensure department compliance/readiness.
- Drive continuous improvement, perform root cause analysis on system failures using tools such as FMEA, Fishbone diagrams, and 5 whys.
Required Skills and Qualifications
- Bachelor's degree in science or engineering.
- 1-3 years of experience in a GMP environment, including quality experience.
- Previous analytical experience.
- Knowledge and experience using systems such as GLIMS, LIMS, and SAP beneficial.
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