Danaher Corporation Senior Quality Compliance Investigator in Fargo, North Dakota
Aldevron is an industry pioneer with a core competency in manufacturing for gene and cell therapy. We supply high-quality plasmid DNA, mRNA and proteins to our clients, who are breaking new ground on the world’s most important and challenging solutions to benefit us all. We're looking for innovative, forward-thinking individuals who share our goals of advancing science and making an impact on the world.
Aldevron is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.
This Senior Quality Compliance Investigator is responsible for working collaboratively with a cross-functional team to investigate non-conforming events and prevent recurrence further bolstering Aldevron’s compliance. This Senior Quality Compliance Investigator will own process improvements and drive these events to closure, creating mechanisms and coordinate activities to assure quality standards are consistently met. Additionally, as the expert in site compliance this individual will facilitate training on robust strategies to identify the true root cause of non-conforming events and applying robust corrective and preventive actions to prevent recurrence. This individual will also help to drive continuous process improvements and work to maintain quality compliance programs that align with company, regulatory, and statutory standards in respect to robustness and closure time.
Collaborate and manage the resolution of root cause investigations, including impact assessments, CAPAs, and product complaints
Work interdepartmentally to drive closure of investigations with teams from Manufacturing Operations, Quality Assurance, and Quality Control
Proactive management of the progression of investigations and CAPAs to timely and compliant closure per established Standard Operating Procedures and Daily Management initiatives
Use of Quality Risk Management and Operational Excellence principles to facilitate risk-based decision-making, drive continuous improvement, and eliminate waste
Facilitate the daily Quality Event criticality assessment
Ensure safe and compliant cGMP operations and contribute to permanent inspection readiness
Coach and mentor colleagues on Quality Event and CAPA Programs best practices and fundamentals
Interface with key internal and external stakeholders
One to three years of experience in Quality; preferably in investigations, CAPAs, and change controls
Experience working in a cGMP compliant environment
Current or past Quality certifications a plus (e.g. ISO 9001, ASQ, etc.)
Any experience in cell and gene therapy or biological manufacturing is a plus
Bachelor of Science, required; life science related field, preferred or equivalent experience
Experience in process understanding as it pertains to cGMP manufacturing and Quality oversight.
Comprehensive understanding of cGMP manufacturing expectations
Exposure to regulatory agency inspections or other types of audits (e.g., FDA, notified bodies, ISO, etc.).
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 email@example.com to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.