QC Analytical Leader
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 QC Analytical Leader works daily within Aldevron’s laboratory performing tasks associated with the testing of material submitted for analysis while providing leadership to the laboratory staff. The supervisor is expected to be familiar with all of Aldevron’s products and how it correlates to methodologies for the testing of this material and interpretation of results.
- Ensure QC Stability Analysts are trained in required procedures for the execution of their role and maintain current training requirements throughout the year. Ensure all stability activities are in accordance with SOP’s and cGMP.
- Lead the analytical daily operations of the Stability Program.
- Support the Stability Manager to provide guidance on products, analysis, growth, and goals.
- Facilitate execution of the established stability strategy across functional areas and across internal and external sites, including stability study initiation, stability sample management, stability storage and stability testing.
- Ensure all stability metrics are captured and reported.
- 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
- Assign responsibilities, establishes work hours, and monitors staffing performance.
- Ensure all background preparation work, such as ordering, is done within a timely manner to prevent delays to the stability workflow.
- Complete training and job coaching with Stability analytical staff to help them fulfil and exceed the requirements of their job.
- Execute CAPAs and deviations within defined timelines.
- Approve documentation of Master Stability Protocols, Study Specific Stability Protocols, Stability Plans, Stability Reports, statistical analysis of stability data and the Annual Stability Report.
- Initiate nonconformance reports for failing materials, Out-of-Spec investigations, Lab Investigations, Root Cause analysis, and CAPA related activities.
5+ years of experience within a GMP regulated Quality unit. relevant professional field.
Bachelor of Science in Biology, Chemistry, or Molecular Biology required
Ability to lead cross-functional teams and collaborate with internal/external partners to enhance relationships and interactions, including interfacing with management.
Ability to work as an effective team leader.
Ability to follow written procedures and verbal directions
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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 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.
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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@example.com to request accommodation.
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