Purpose :
The Specialist Quality Systems is responsible for providing quality assurance support for some or all of 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 product, process or system related quality activities from raw material inspection through shipment of final product are in compliance with Corporate and governmental regulations.
Qualifications :
- 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.
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority / Gender / Disability / Religion / LGBTQI / Age / Veterans.
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