Purpose

The Sr 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

• Ensure 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.
• Responsible for developing a process to maintain citation history.

• Monitor changes to legislation, regulations and statutes that may impact retention and/or require changes to the AbbVie Record Retention Schedule.
• Create quality system documentation and specifications with guidance from technical teams following approved templates and guidelines.
• Complete and route change requests for process document creation, maintenance, and implementation.
• Design effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality system. May be required to prepare and present data during regulatory audits (FDA, EMA, Anvisa, etc) and internal audits.
• Interact with internal and external partners for development of best practices in our quality systems and procedures.
• Perform assessments to determine compliance to processes and regulations to identify potential gaps and mitigate and implement improvements within our quality system.
• Contribute and prepare training and education programs for various aspects of quality assurance.