- 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.
- 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
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.
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Quality Assurance Associate, A2 Shift - Woodway, United States - AbbVie
Description
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
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
Qualifications
A2 Shift - 7am-7pm Sunday/Monday/Tuesday & every other Saturday
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
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.
