Danaher Corporation Quality Document Control Leader 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.
In this role, you will have the opportunity to:
Provide leadership, mentoring, and supervision to the Document Control team
Oversee day-to-day activities, including document distribution, reconciliation, and storage
Write, review, and revise standard operating procedures as needed
Work productively with cross-functional teams within the organization to support operations
Develop, justify, and implement process improvements and standards
Track, trend, and report document reporting metrics
Provide quality support for client and regulatory audits.
The essential requirements of the job include:
Demonstrated effective communication and interpersonal skills across all functions.
Experience in process understanding as it pertains to cGMP manufacturing and Quality Assurance.
Comprehensive understanding of regulatory expectations surrounding document issuance, storage, and reconciliation.
Exposure to regulatory agency inspections or other types of audits (e.g. FDA, notified bodies, ISO, etc.).
Ability to thoughtfully analyze a wide variety of information and data to make key decisions regarding potential risks associated with product quality or regulatory violations.
Ability to effectively lead and motivate a team of direct reports, provide unifying vision, build on strengths, and address areas of improvement.
Ability to manage priorities, track progress of key projects, and provide updates to leadership as required.
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 firstname.lastname@example.org to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.