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.
Job Summary
The primary function of this role is to provide Quality and compliance leadership and direct supervision for in-process reviews of manufacturing, packaging, labeling, laboratory operations, technical services, storage, distribution, and quality systems at Aldevron. This individual will support and execute company directives, policies, processes, and procedures in support of this objective. Additionally, the OQA Supervisor (2nd Shift) will help resolve any quality issues on areas of oversight that impact manufacturing delays and successfully address complex problems or development and implementation of robust preventative or corrective actions to enhance overall operational reviews.
This position is 2nd shift.
Job Responsibilities
- Manage, train, develop, and mentor a team of OQA professionals while providing technical input and justification for release or rejection of OQA reviews
- Provides ‘on-the-floor’ Quality oversight of manufacturing, inspection, packaging, labeling, warehousing, and provides timely input to enable compliant and timely operations
- Serves as the Subject Matter Expert (SME) in assessing the impact of excursions and deviations that occur during operations
- Performs “real time” batch record review on the floor to reduce or eliminate errors and improve Right First Time (RFT)
- Supports a program to ensure timely batch record review, resolution of batch-related investigations and review of laboratory test results, to enable a smooth release of finished product
- Collaborate with internal partners in other parts of Quality Assurance (QA), Quality Control (QC), Technical Operations, manufacturing , and Supply Chain to resolve issues
- Manages reviewed and in-process documentation necessary for in-process releases including solution preparations, in-process QC testing and SOPs
Qualifications
- 3+ years of relevant experience in a quality position, required
- 2+ years of that experience in a lead, supervisory or managerial position
- Direct experience with regulatory or internal audits and inspections
- Bachelor of Science preferred.
- Life science related field preferred or equivalent experience.
- 5% travel
Additional Skills
- Experience in process understanding as it pertains to cGMP manufacturing
- Comprehensive understanding of cGMP manufacturing expectations
- Exposure to regulatory agency inspections or other types of audits (e.g. FDA, notified bodies, ISO, etc.).
#LI-LCS
Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit www.danaher.com.
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.
The U.S. EEO posters are available here.
We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or [email protected].
Top Skills
What We Do
Beckman Coulter is committed to advancing healthcare for every person by applying the power of science, technology, and the passion and creativity of our teams to enhance the diagnostic laboratory’s role in improving healthcare outcomes. Our diagnostic systems are used in complex biomedical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. Beckman Coulter offers a unique combination of people, processes and solutions designed to elevate the performance of clinical laboratories and healthcare networks. We do this by accelerating care with a menu that matters, bringing the benefit of automation to all, delivering greater insights through clinical informatics and unlocking hidden value through performance partnership. An operating company of Danaher Corporation since 2011, Beckman Coulter is headquartered in Brea, Calif., and has more than 11,000 global associates working diligently to make the world a healthier place.
