Purpose :

Describes the primary goals,objective or function or outputs of this position.

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.

Responsibilities :

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

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

Assist 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.

Assist with or co-lead audits of documentation, facilities and equipment.

Assist 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 to 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.

List required and preferred qualifications up to 10). Include education, skills and experience.

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 team 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.