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Form of workThe Senior Associate II of QA Regulatory will provide leadership and direction to the Quality Function within Operations. The primary responsibility is to ensure the effective implementation of Quality functions within their area, which encompasses Product Quality Assurance, Validation, Training, Regulatory Compliance, Quality Planning, Product Quality, and strategic initiatives. It is expected that the Sr. Quality Associate II will maintain superior quality standards while prioritizing efficiency in all aspects of their job. Don't miss the chance to join our team and demonstrate your expertise in the field of Quality Assurance. Take the next step in your career and apply today.
Responsibilities:
- Leads and influences peers and colleagues within the scope of their work.
- Responsible for various aspects of quality assurance related to products produced at the plant.
- Responsible for the effective organization, administration, and training within their functional area.
- Independently troubleshoot and resolve quality compliance issues.
- Provides regulatory and technical guidance to departments.
- Communicates with Management for Product Quality Review, Quality Initiatives, reports/memo, etc.
- Responsible for quality decisions related to their functional area to ensure compliance with AbbVie Quality Systems and cGMPs.
- Bachelor's Degree required; preferably in Physical or Life Sciences, Pharmacy, or Engineering
- 8 years of combined experience in Manufacturing, QA, R&;D in pharmaceutical, biologics, device or chemical industry
- Must be familiar with use of electronic document management and laboratory information management.
- Must also be familiar with Quality Systems as well as cGMP and other regulatory requirements.
- Strong communication Skills, both verbal and written
