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QA Specialist II

Waukegan, ILRandstad LifeSciences


Chat with me now! - https://flashrecruit.com/jobs/300294
 

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. 

  • 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.

Position Requirements

  • Bachelor’s 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.

Benefits

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

 


Chat with me now! - https://flashrecruit.com/jobs/300294