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Clinical Quality Assurance Technician

Hunter International
Parsippany, NJ
  • Posted: over a month ago
  • Full-Time
Job Description
Clinical Quality Assurance Technician
ParsippanyNJ
Pay: 37-41
 
The Clinical Quality Assurance Technician will primarily support Scientific Laboratory Services (SLS) Quality Assurance activities at all locations.
 
Clinical Quality Assurance Technician Responsibilities
  • Ensure SLS quality systems are maintained consistent with cGMPs, Pfizer policies, site procedures and regulatory guidance. The quality systems to be maintained include laboratory investigations, instrument/facility qualifications, analytical method validation and transfers, deviation management, notification to management, corrective and preventive actions (CAPAs), site quality review team (SQRT) and change management.
  • Ensure testing/administration is conducted in a manner consistent with cGMPs, Pfizer policies, site procedures and regulatory guidance.
  • Review/approve various types of laboratory documentation ensuring that strong scientific justification, adequate impact assessments and appropriate definition of root cause and corrective actions are identified. These documents would include stability study change control, equipment change control, corrective and preventive actions, quality notification reports, testing notes, instrument/facility qualifications, analytical method validation and transfers and laboratory investigation reports.
  • Able to interpret quality requirements, both internal and external, and apply them to real life situations in the pharmaceutical industry.
  • Work together with the SLS management to assure that objectives and metrics are met.
  • Create, track and approve corrective/preventive action items to help ensure they are completed within the agreed timeframes.
 
Clinical Quality Assurance Technician Qualifications
  • Must have QA experience 
  • Document review, customer facing, great communication
  • GMP, or GLP experience in a Pharma or Medical Device industry
  • Trackwise or another electronic investigation system preferred
 

Hunter International

Address

Parsippany, NJ
USA

Industry

Manufacturing

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