Quality Systems Specialist

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.

Created: 2024-11-05