QA IT Lead

Rensselaer, New York

 Katalyst Healthcares and Life Sciences
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Responsibilities:
  • Ensure IT processes and procedures meet Quality System requirements.
  • Participate and support the Quality Risk Management (QRM) principles in the formal and informal risk assessment initiatives.
  • Support the development, review and approval of Quality Assurance Agreements (QAA), along with the Approved Supplier List (ASL) process.
  • Collaborate with other functional areas to collect information and provide guidance through all stages of the quality management system and improvement projects.
  • Ensures new systems/processes/procedures are compliant with SOPs, WIs and data and regulatory guidelines for IT and Software validation process.
  • Assist in resolution of inspection management concerns as it relates to software applications process, procedures, and data integrity.
Requirements:
  • Bachelor's degree in a relevant field (e.g., Life Science, Computer Science, Engineering, Information Technology) preferred.
  • 100% Pharma Manufacturing at least the last 7 years, Data Integrity, Deviations, GXP, IT QA Systems hardware servers, CAPA's SOPS Training Audits, FDA ALL PRE-CSV Validation.
  • This is not TESTER, or Validations role.
  • The Senior QA Specialist will serve as SME by supporting investigations, risk assessments, and IT Operations while verifying that GxP computerized systems operate as expected post-validation.
  • 7+ years of experience in IT, Computer Science, Engineering, or Chemistry in an FDA regulated manufacturing environment.
  • Thorough understanding of IT CSV and QA IT roles and responsibilities in support of GxP compliance is required.
  • Experience working in an FDA regulated environment with a strong emphasis on a risk-based approach to validation/qualification.
  • Strong knowledge of FDA CFRs, Eudralex, and other biotech/pharma industry regulations (pertaining to IT, laboratory systems, automation, and manufacturing).
  • Strong knowledge of Data Integrity, System Development Life Cycle (SDLC) validation methodology and Software Quality requirements.
  • Understanding of root cause analysis and risk management techniques.
  • Experience with quality management systems including change control, incident management, and deviation management.
  • Strong Project Management experience leading efforts requiring coordination between cross functional teams within at least one area of systems validation - e.g., laboratory equipment, facilities, utilities, manufacturing equipment, information systems, etc.
Date Posted: 15 May 2025
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