USA-Quality Control Technician II (Manufacturing/Quality) 1st Shift

Title: Quality Control Technician II
Location: Swiftwater, PA
Duration: 24 Months

Job Summary:
Description This position will support the lifecycle management of instrumentation within the Quality Control department at the Swiftwater, PA location while strictly adhering to procedures, Health Authority Regulations, and cGMP's.

Main Responsibilities:
• Provide instrumentation support that impacts the Quality Control Laboratory including qualification, calibration, and preventive maintenance
• Assist in completion of change controls, deviations, CAPA's to support timelines
• Author cGMP documentation including protocols, reports, procedures, and user requirement specifications
• Assist in implementing new technologies to improve QC testing efficiency and capabilities
• Support QC laboratory inspection readiness
• Develop an understanding of best practices for optimal equipment operation and compliance to regulatory requirements
• Follow cGMPs and strictly adhere to *** policies and procedures
• Complete required training as assigned

Technical Competencies:
• Working knowledge of cGMP's, Regulatory requirements, and data integrity concepts
• Ability to work cross-functionally with other departments and involved stakeholders
• Lead projects related to analytical instrumentation
• Aptitude working within computerized systems
• Understanding of analytical instrumentation concepts and technologies
• Strength in *** Play to Win Behaviors – Stretch, Take Action, Act for Patients and Customers, Think *** First

Basic Qualifications:
• Bachelor's or Master's degree in Life Sciences or Engineering is required
• 2+ years' experience in a cGMP laboratory setting
• Vaccinations as required

Preferred Qualifications:
• Demonstrated customer focus and experience in support roles
• Prior experience maintaining laboratory instrumentation
• 3+ years' experience in cGMP laboratory setting

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