Purpose
The Quality Associate supports the Quality Function that they are responsible for within Operations.
As a member of the Quality function, provides real-time shop floor oversight to the assigned operations.
Partners with Site colleagues to create an environment of the highest performance standards for the operations.
Drives continuous improvement in the Operations on site.
Responsibilities
Responsible for various aspects of quality assurance and quality control related to their functional area.
Ensures that product within the plant is consistently manufactured in conformance with AbbVie Quality System requirements and all applicable regulatory requirements.
Partners with Manufacturing SMEs and Shift Supervisors to drive performance of the shift team.
Completes real-time review of Batch Record documentation and Manufacturing logs.
Actively supports Quality investigations.
Completing training activities as required and actively coaching and mentoring colleagues who work in Cleanrooms.
Participates in routine leadership GEMBAs of Manufacturing and Laboratory areas.
Provides key input to the development and maintenance of the Site Contamination Control Strategy.
Provides key input to the assessment of EM data and trends.
Serve as an expert and as a consultant in clean room good practices and behaviors.
Qualifications
Associate Degree in a Science, Quality or Engineering discipline or equivalent related work experience.
4+ years of experience in a pharmaceutical and/or medical device regulated environment
Knowledge of Regulatory Requirements
Excellent communication skills
A2 Shift - 7am-7pm Sunday/Monday/Tuesday & every other Saturday
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.
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