Job Information
Danaher Corporation Quality Lab Manager in Fargo, North Dakota
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.
The Quality Lab Manager manages Aldevron’s Sequencing laboratory activities and personnel to assure effective, efficient, and compliant adherence to all company policies, procedures, and cGMP requirements.
Essential Functions
Ensure generation of staff daily work instructions and completion of the necessary testing in support of the daily operations of the laboratory
Ensure all lot tracking reporting, status reporting and applicable laboratory metrics are populated
Oversee the administration of staff to ensure that members are adequately trained, developed and motivated, and that they adhere to quality performance standards
Identify ways to optimize testing processes, assay setup, layout, and job execution that improves lab workflow
Contribute to reviewing and updating technical SOPs, forms and report templates
Identify problems that may adversely affect test performance, takes authorized corrective action, and notifies management
Oversee laboratory personnel to ensure following established standard operating procedures for material handling and processing, testing, data analysis, and reporting of results
Ensure all background preparation work, such as ordering, is done within a timely manner to prevent delays to the manufacturing schedule
Assist Client Relations/Project Management with responding to testing related questions received from clients as needed
Complete training and job coaching with laboratory staff to help them fulfil and exceed the requirements of their job
Execute CAPAs and deviations within defined timelines
Communicate the status of operations, process issues, and safety and maintenance issues to Management
Update Client Relations and Project Management on testing status within the defined system and as needed
Perform routine maintenance of laboratory equipment or ensure contracted service maintenance is scheduled with sufficient lead time to ensure completion of activities prior to due date
Initiate nonconformance reports for failing materials, Out-of-Spec investigations, Lab Investigations, Root Cause and CAPA related activities
Qualifications
Experience:
7+ years of related industry experience. Sanger or Next-Generation Sequencing experience preferred
Experience managing teams
Experience in qualifying sequencing assays to be used in a GMP environment preferred
Experience working within a GMP/regulated environment, under a Quality System
Education
Bachelor of Science in Biology, Chemistry, or Molecular Biology required
Master’s degree preferred with equivalent experience
#LI-LM1.
When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.
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 (https://www.dol.gov/agencies/ofccp/posters) .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 applyassistance@danaher.com to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.