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Quality Systems Associate Specialist

Job Overview

The Quality Systems Associate Specialist is responsible for providing quality assurance support for some or all of the following manufacturing processes: pharmaceutical products, medical devices, combination products and biologics.

Key points

  1. Specific areas of support may include the Document Center, Device QA, Labeling, Validation, Training and CAPA.

  2. This position will ensure that all product, process or system related quality activities from raw material inspection through shipment of final product are in…

  3. Assist with proper integration and support of quality regulations: drug, biologics, device and/or combination products.

  4. Assist project teams in planning, preparation, review and approval of quality documentation.

  5. Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area preferred.

  6. Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences, Manufacturing Operations.

  7. Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical, biological or device related products preferred.

  8. Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device, biologics, and pharmaceutical products preferred.

Skills

Communication

Experience: Entry-level · 3+ years · Job type: Full-time