23 Dec
Quality Engineer II
Illinois, Northchicago , 60088 Northchicago USA

Position Details:Job Title: Quality Engineer IILocation: North Chicago, Illinois - 60064Duration: 7+ months(+extension)

Description:

Responsibilities
  • Provide interpretation and guidance regarding qualification and validation requirements in GLP-, Google Cloud Platform- and GMP-regulated areas of an R&D organization.
  • Review / approve various qualification / validation plan documents, test strategies, test documents, summaries, and certification packages and associated deliverables as appropriate with minimal supervision.
  • Compilation, review and approval of quality documents (Policies, Processes, Procedures, templates, formats etc.).
  • Support CAPA activities related to validation and qualification
  • Provide guidance, direction, and support to peers.
  • Provide assurance that applicable national and international regulatory requirements are adhered to in the context of validation and qualification policies, processes, and procedures.
  • Lead or participate on process improvement projects and assist with the development of compliance plans and strategies.
  • Review new / updated regulations and provide comments on and assessments of how the new / updated regulations impact the organization.
  • Participate in preparation and execution of authority inspections, self- inspections, vendor audits, presentation of validation concepts and system validations.
Represent R&D QA in cross functional global expert teams, industrial and professional associations.

Education/Requirements:4 year college degree; preferably a BS in Chemistry, Biology, Engineering Pharmacy, or Microbiology.

  • Minimum of 5 years of experience in Quality Assurance or related field such as regulated GxP environment in qualification / validation, documentation or compliance.
  • Sound knowledge of the current regulatory requirements (21 CFR Part 11, EU GMP Annex 11 / 15, ICH, PIC/S) and Best Practices (GAMP5, Data Integrity, etc.)
  • Conducting or providing QA oversight of Equipment, Facility, Utility, Instrument qualification and Cleaning, Automated Process Controller, and Test Method validation.
  • Excellent communication capabilities and teamwork capacities.
  • Proven ability to work in a global environment and on virtual teams.
Experience leading cross-functional teams or change initiatives

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