Quality Assurance Coordinator
PharmaMedTechRegulatory AffairsQuality Assurancegmpemafdacroinformsap
Job description
The Opportunity: Avantor is looking for a Quality Assurance Coordinator to join our Quality Department! This is a full-time , onsite position based at our Paris, KY facility and scheduled to support second shift operations. The working hours for this role will be Monday – Friday, 3:30pm – 12:00am EST . What we’re looking for Education: High School completion or equivalent (GED) is required Experience: No minimum years of experience required; Experience in quality assurance within a manufacturing environment, including auditing activities, is preferred Strong familiarity and understanding of regulatory and quality assurance procedures, systems, and operations Collaboration Tool: Proficient in Microsoft Office Suite Preferred Qualifications: Experience with SAP highly preferred Familiarity with chemical nomenclature and manufacturing terminology Knowledge of FDA regulations and cGMP requirements How you will thrive and create an impact The Coordinator will ensure product quality and regulatory compliance by executing quality assurance processes, conducting inspections, reviewing documentation, and monitoring production activities. Partners cross-functionally with manufacturing, suppliers, and auditors to resolve quality issues, support corrective actions, and maintain compliance standards. Continuously improves testing methods and quality procedures to support new products, address deviations, and adapt to evolving regulatory requirements. Match MPOs and bench sheets for finished goods and perform audits of job packets Release materials in IMS and maintain MPO audit logs, including audit metrics and results Maintain filing and storage of quality records Print, cut, count, verify, package, and issue label packets according to production schedules Issue packaging jobs to production Maintain the stability storage area and collect monthly stability samples Perform internal audits as scheduled Maintain inventory quality status and support Material Review Board (MRB) activities Manage hazardous and universal waste in accordance with local, state, and federal regulations Perform other duties as assigned, with or without accommodation KNOWLEDGE SKILLS AND ABILITIES (Those necessary to perform the job competently): Strong interpersonal and relationship-building skills Ability to manage multiple priorities and meet deadlines Excellent verbal and written communication skills Strong attention to detail and organizational skills Demonstrated initiative, accountability, and sense of urgency Ability to work independently and manage time effectively Sound judgment and professionalism Ability to learn and navigate multiple software systems ENVIRONMENTAL WORKING CONDITIONS & PHYSICAL EFFORT (Under Typical Positions) The work environment characteristics and physical effort described here are representative of those an associate encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the associate is exposed to an industrial warehouse environment. The associate works near moving mechanical machinery in the work environment. #LI-Onsite Disclaimer: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer. Why Avantor? Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science. The work we do changes people's lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor. We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today! EEO Statement: We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law. If you need a reasonable accommodation for any part of the employment process, please contact us by email at recruiting@avantorsciences.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address. For more information about equal employment opportunity protections, please view the Know Your Rights poster . Privacy Policy: We will use the personal information that you have submitted to us in order to consider your application for the relevant role. Your privacy is important to us. Please click here for our Privacy Policy which explains the purposes for which we will use your personal information and the ways in which we will handle and retain your information. It also explains the rights you have in relation to your information, and how to contact us with any queries or requests. 3rd Party Non-Solicitation Policy: By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferre
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