Senior Specialist, Quality Systems

Role Summary

The Senior Specialist, Quality Systems provides quality assurance support across manufacturing processes including pharmaceutical products, medical devices, combination products, and biologics. Key areas include the Document Center, Device QA, Labeling, Validation, Training and CAPA. The role ensures that all product-, process-, and system-related quality activities—from raw material inspection through final product shipment—comply 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.

Qualifications

• Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area preferred.
• 5+ 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.
• Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device, biologics, and pharmaceutical products.
• Experience working in both team setting and independently. Works well with manager guidance while able to manage own time.
• Strong oral (with all levels of management) and written communication skills needed.
• Excellent interpersonal skills a plus.
• Runs and manages small to medium sized quality related projects.