Job Description

Title: QA Review / Lab Systems Validation Specialist

Type of Role: Contract - 12+ months

Location: Morrisville, North Carolina

Provide QA review/oversight for GXP computer systems validation (focus on Laboratory Systems) by conducting the review and approval of executed validation protocols and associated discrepancies for computerized Laboratory systems.

Experience with Lab Systems, ie. Waters NuGenesis, Empower SDMS, LabVantage or LabWare LIMS highly preferred.
• Provide QA assessment and approval for GXP computer system changes
• Demonstrates in-depth knowledge of QA systems principles, concepts, industry practices, and standards.
• Support and maintain Quality Assurance programs, policies, processes, procedures and controls ensuring compliance with
current Good Manufacturing Practices (cGMP) expectations and established agency requirements/guidelines.
• Investigates and troubleshoots problems which occur and determine solutions or recommendations for changes and/or
improvements and adherence to cGMPs.
• Reviews, edits and approves change control and SOPs.
• Strong understanding of the current pharmaceutical industry and applicable regulations, with emphasis in 21 CFR Part 11,
210, 211, 58 and 820 compliance.
• Strong knowledge of appropriate Quality Systems and cGMP requirements (FDA, EU, ICH) with the ability to assess
compliance risks.
• Strong working knowledge in validation methodology and software development life cycle (SDLC) principles.
• Must have excellent communication skills (both oral and written including the ability to effectively communicate across
organizational levels and functions.
• 7+ years of work experience in QA or Validation performing protocol review and approval associated with the
implementation and maintenance of computerized systems in pharma/biotech or medical device environment.

Application Instructions

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