Westport, Westport

Posted 8 days ago

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Job Description

Support NPI QC Testing on PSBs, Clinical, PPQ, Demo and investigational lots via Cell Based Potency Assay and related [LISA methods.
Timely review of testing records and all associated documentation.
Routine lab duties including critical reagent qualifications, inventory
management and equipment maintenance.
Perform all activities are completed in line with regulatory (QA and (HS) and corporate requirements.
Open and progress QMS records as required – Laboratory Investigations, Change Controls
Complete assigned training on time
Understand regulations and business processes required to maintain laboratory data integrity
Provide input on assay performance monitoring and trending
Supporting Root Cause Analysis Investigations
Attend departmental and Tier meetings

Skills & Technologies

Cell Based Potency Assay ELISA Laboratory Investigations Root Cause Analysis Data Integrity Regulatory Compliance (QA/GMP)QMS (Quality Management Systems)Change Controls Critical Reagent Qualification Inventory Management

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Salary Information

Salary: $95000-125000

🤖 This salary estimate is calculated by AI based on the job title, location, company, and market data. Use this as a guide for salary expectations or negotiations. The actual salary may vary based on your experience, qualifications, and company policies.

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