Purpose
The Sr Quality Associate II provides leadership and direction to the Quality Function that they are responsible for within Operations.
This role is responsible for the effective implementation of the Quality functions within operations for which they would be responsible for.
This could include: Incoming Quality Assurance of drugs and packaging materials, Manufacturing Quality Assurance, Validation, Training, Regulatory Compliance, Quality Planning, Product Quality and strategic initiatives.
The Sr Quality Associate II would be expected to work within a budget and leads a team who are responsible for compliance and quality systems implementation.
Expectations that the Sr.
Quality Associate II will maintain high quality levels on all aspects of their job while achieving high levels of efficiency.
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 Quality Management Review, Quality Initiatives, etc.
Incumbent is responsible for quality decisions related to their functional area to ensure compliance with AbbVie Quality Systems and cGMPs.
Qualifications
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 AbbVie Quality Systems as well as cGMP and other regulatory requirements.
Strong communication Skills, both oral and written.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion.
It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
Whatsapp
