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Quality Assurance (QA) Specialist I

Waukegan, ILRandstad LifeSciences


Chat with me now! - https://flashrecruit.com/jobs/301332
 

Job Title:  Specialist, Quality Systems


Position Description

  • The Specialist, Quality Systems is responsible for providing quality assurance support for some or all of the following quality systems: Lot Restriction Management System (LRMS), Trackwise, attache/attache PRO, and SAP.
  • Specific areas of support may include the configuration and implementation of pharmaceutical products, medical devices, combination products and biologics.
  • This position will ensure that integrity, accuracy, consistency and completeness of data processed within designated Quality System are in compliance with Corporate and governmental regulations.

Position Responsibilities

  • Support project teams in planning, preparation, review and approval of quality documentation.
  • Create quality system documentation with guidance from technical teams following approved templates and guidelines.
  • Collect and compile key quality metric data.
  • Assist with processing restriction approvals within designate Quality Management System.

Position Requirements

  • Bachelors Degree (Chemistry, Pharmacy, Biology, Engineering or other technical/ scientific area preferred) or equivalent experience.
  • 3+ years experience in quality assurance, quality oversight or relevant experience.
  • Technical knowledge in as many of the following areas as possible; Quality, Regulatory, Process.
  • Knowledge and familiarity with product, process of pharmaceutical, biological or device related products preferred.
  • Working knowledge of Trackwise system change management module.
  • Working knowledge of attache/attache PRO document management system.
  • Working knowledge of SAP; Quality Module.
  • Able to work independently and/or function with minimal supervision. Must be able to work under pressure and stress common to office environments.
  • Must be able to maintain a high degree of accuracy and analytical thinking.
  • Experience working in both team setting and independently. Works well with manager guidance to complete tactical objectives while able to manage own time effectively.
  • Perform assessments to determine compliance to processes and regulations to identify potential gaps and suggest improvements within our quality system. Assist in the design of effective quality systems, procedures and/or processes to ensure compliance as well as efficiency throughout our quality system.
  • Participate in training and education programs for various aspects of quality assurance.
  • Must have Advanced knowledge of Microsoft Office Suite, Adobe Acrobat, Visio, and Access.

Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

 


Chat with me now! - https://flashrecruit.com/jobs/301332