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AbbVie

Aseptic MQA

Career Insights for Quality Assurance Supervisor

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What they do

A Quality Assurance Supervisor supervises quality assurance staff and oversees processes involved in the prevention of faults in manufactured products and solutions.

$76,624 / year median in Missouri

+3% projected growth

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Job Description

Company Description About AbbVie 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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube. Job Description As a member of the Quality function, provides real-time shop floor oversight to Aseptic operations, both manufacturing, sampling and testing. Partners with Site colleagues to create an environment of the highest performance standards of Aseptic operations. Drives continuous improvement in Aseptic Operations on site. This role requires shift work. Responsibilities specific to Aseptic Manufacturing (in addition to other duties as assigned): Act as site Subject Matter Expert for Aseptic Operations (Manufacturing, sampling and associated testing). Ensures Aseptic operations are carried out as per Site Procedures. Continuously observes the Aseptic technique and behavior of the shift team, providing feedback as appropriate. Intervention can include a ceasing of manufacturing and testing operations if deemed appropriate. Drives a culture of Speak-Up. Drives all aspects of Aseptic Performance of the shift team through observation and feedback. Drives all aspects of Aseptic performance during sampling and testing. Partners with Aseptic Mentors and Shift Supervisors to drive performance of the shift team. Completes real-time review of Batch Record documentation. Supports training activities and actively coaches and mentors colleagues who work in Cleanrooms. Provides Quality Oversight during critical Aseptic activities such as Cleaning, Sanitization, Aseptic Set-up, sampling, EM plate handling, sample testing and Interventions. Participates and provides leadership to the Site Aseptics team, highlighting and leading introduction of continuous improvement in Aseptic procedures. Provides input and guidance on changes related to Aseptic Manufacturing, sampling and associated testing. Drives a high-performance Aseptic culture across the site. Actively leads and supports investigations. Reviews and Audits Batch Records real-time Reviews and Audits Manufacturing and Testing logs as required. Completion of Line Clearance activities Participate 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. Qualifications Third Level Degree in a Science, Quality or Engineering discipline. 3+ Years of experience in a GMP Environment with 3+ years of experience in support of Aseptic Manufacturing Strong knowledge of Regulatory Requirements Excellent communication skills Additional Information AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html Recruitment Fraud Alert We have recently become aware of various recruitment phishing scams targeting job seekers.
Please be advised:
AbbVie will never request sensitive personal information (such as bank account details, social security numbers, or payment of any kind) during the recruitment process. If you suspect you have received a fraudulent offer or communication claiming to be from AbbVie, please do not respond, open any attachments, or click on any hyperlinks. If you have any questions or concerns regarding the authenticity of a communication alleged to have been made by or on behalf of AbbVie, please contact us immediately. Protect yourself by verifying job offers and communications. Your safety is important to us.
Pay Range:
$ - Where We Work Role is exclusively performed at a site or office and onsite presence is required. Employees who are site/office-based and can occasionally perform their role virtually work both in the office and remotely•, following the policies and regulations in place at their location. US Employees must be in the office on Tuesday, Wednesday, and Thursday with flexibility to work remotely on Mondays and Fridays. Three days in the office is the minimum; some individuals or teams may require more in-office days due to meetings, business/project needs or their role.
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