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Quality Systems Specialist

3 months ago

Highland Park, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • ssist with proper integration and support of quality regulations: drug, biologics, device and/or combination products.
  • ssist project teams in planning, preparation, review and approval of quality documentation.
  • Complete and route change requests for process document creation, maintenance, and implementation.
  • Create quality system documentation and specifications with guidance from technical teams following approved templates and guidelines.
  • ssist with or co-lead audits of documentation, facilities and equipment.
  • ssist in the design of effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality system.
  • Perform assessments to determine compliance with processes and regulations to identify potential gaps and mitigate and implement improvements within our quality system.
  • Participate in training and education programs for various aspects of quality assurance.
  • Specialist Quality Systems is responsible for providing quality assurance support for some or all the following manufacturing processes: pharmaceutical products, medical devices, combination products and biologics.
  • Specific areas of support may include the Document Center, Device QA, Labeling, Validation, Training and CAPA.
  • This position will ensure that all products, process or system related quality activities from raw material inspection through shipment of final product are following Corporate and governmental regulations.
Requirements:
  • Bachelor's degree in chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area preferred.
  • 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 Sciences, Manufacturing Operations.
  • Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical, biological or device related products preferred.
  • Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device, biologics, and pharmaceutical products preferred.
  • Experience working in both teams setting and independently.
  • Works well with manager guidance to complete tactical objectives while able to manage own time effectively.
  • Strong oral and written communication skills needed.
  • Excellent interpersonal skills a plus.
  • Runs small projects to deliver tactical results.
  • Bachelor's Degree 3+ years' experience in quality assurance, quality oversight or relevant experience.
  • Quality mindset.
  • MS Office (Excel-average experience).
  • Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device, biologics, and pharmaceutical products preferred.
  • Strong oral and written communication skills needed.
  • Experience working in both teams setting and independently.
  • Works well with manager guidance to complete tactical objectives while able to manage own time effectively.
  • Bachelor's degree in chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area preferred.
  • Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical, biological or device related products preferred.