- Review Quality System records inclusive of complex Deviations, CAPAs, and Change controls. This would be the quality review responsible for approval as quality entity ensuring compliance of the record to governing regulations. This is final review then goes to client.
- Lead Daily Management activities to ensure timely completion of Quality System records.
- Assess atypical events through cross-functional collaboration to ascertain product impact. Lead Deviation Triage meeting and serve as Quality department stakeholder.
- Support quality project that will Enhance site wide compliance by working with Operational and other Quality stakeholders.
- Assist with training junior associates on the requirements of Quality System records, including mentoring of Quality System owners and reviewers and support cross-training in other functional areas of QA as requested by management.
The essential requirements of the job include: - Bachelor degree with 2+ years of experience or 4+ years experience in a compliance role.
- 2+ years quality assurance experience within a regulated industry, experience in pharmaceuticals may be substituted.
- Previous experience with Quality System records.
It would be a plus if you also possess previous experience in: - Biologics or drug experience a bonus
- Certification from ASQ or RAPS a plus
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Quality Compliance Associate II - Fargo, United States - Danaher Corporation
Description
At Aldevron, we shape the future of medicine by advancing science in meaningful ways. Our team of dedicated, forward-thinking associates share this goal by combining best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. We believe people are our most valuable asset. Whether this is your first step on a rewarding career path or are a seasoned professional ready to take your career to the next level, we hire the best from all backgrounds and experiences.
Aldevron is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.
This position, Quality Compliance Associate II, is part of the Quality Assurance Team located in Fargo, ND and will be onsite. At Aldevron, we combine best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. You will be a part of the Quality Compliance Team and report to the Manager of Quality Compliance responsible for management of the Quality Systems implemented by Aldevron.
In this role, you will have the opportunity to:
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
The EEO posters are available here ) .
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at to request accommodation.
