Operational Quality Assurance Lead

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 is a senior level position in Operational Quality Assurance (OQA) located in Fargo, ND and will be onsite working a first shift position. 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 Assurance team and report to the Manager, Operational QA. The OQA Lead activities include but are not limited to training, mentoring, and coaching lower level OQA associates and driving coordination of real time review activities.

In this role, you will have the opportunity to:

• Cross functional support including gap analysis, FMEA, risk assessments, root cause analysis, tracking and trending, statistical modelling (linear regression, T-test, control charts, etc.), and develop/maintain client specific process datasets, as needed. Able to follow, revise, and edit SOPs and forms to confirm compliance to a standard.

• Coordination and responsibility for collaboration with Manufacturing in respect to any Quality related actives identified during manufacturing. Perform GMP oversight, and “real time” review of manufacturing documentation including batch records and protocols during execution. Monitor and auditing processes to ensure protocols are being met.

• This role performs timely reviews of all batch documentation; assure that batch records are complete, correct, accurate, and satisfy all current Good Manufacturing Practices (cGMP) and all current Good Documentation Practices (cGDP) expectations.

• Interfaces with technical operations to develop an understating of the critical process parameters associated with manufacturing deviations that can impact product Quality, Safety Purity, or Effectiveness. Provide technical Quality oversight to manufacturing Quality Events investigations. Interface with regulatory agencies and customers to provide timely documentation

• Perform evaluations of proposed changes to the manufacturing process, materials, components, or records to determine the effect on the manufactured product. Recommendations to correct, enhance, improve, or optimize any underperforming process & creating and amending work instructions, as needed

The essential requirements of the job include:

• 5+ years of experience in a Quality, auditing, or GMP Manufacturing role. If experience is in an equivalent GMP facility, such as biotech, pharma, medical device manufacturing, etc.

• Experience working in a regulated or GMP compliant environment. Current or past Quality or auditing certifications a plus (e.g., ISO 9001, ASQ registered inspector, certified internal auditor, etc.)

• High School Diploma or GED equivalent.

At Danaher we bring together science, technology and operational capabilities to 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. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. 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. 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.

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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 [email protected] to request accommodation.