AbbVie Quality Systems Associate Specialist at AbbVie provides quality assurance support for manufacturing processes including pharmaceutical products and medical devices. Ensures compliance with corporate and governmental regulations.
Responsibilities
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.
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.
Qualification
Bachelor’s Degree in ChemistryTechnical knowledge in QualityKnowledge of pharmaceutical
Required
Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area preferred
3+ years’ experience in quality assurance or relevant experience
Technical knowledge in Quality, Regulatory, Process Sciences, Manufacturing Operations
Knowledge of pharmaceutical, biological or device related products preferred
Knowledge of QA systems and GMP compliance requirements preferred
Experience working in team setting and independently
