QA Review / Lab Systems Validation Specialist
|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
• 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.