Documentation Specialist

Danaher CorporationMiami, FL
Onsite

About The Position

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Beckman Coulter Diagnostics, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory’s role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, more than one million tests are run on Beckman Coulter Diagnostics systems, impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making—we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence. Learn about the Danaher Business System which makes everything possible. The Manufacturing Documentation Specialist at Beckman Coulter will be responsible for document creation and management. This role will work closely with manufacturing engineers to update and revise existing work instructions to reflect design and process changes or improvements. Additionally, the documentation specialist will manage various manufacturing quality records such as but not limited to: SPC, pFMEA maintenance, support engineering change order implementation, equipment PM documentation management, TWI storage, to ensure compliance to quality and regulatory standards This position will report to the Senior Manufacturing/Processing Engineering leader, be a part of the Manufacturing Technical Operations team located in Miami FL and will be fully on-site. In this role, you will have the opportunity to:

Requirements

  • Associate degree or higher in drafting, engineering, or a related field (Mechanical Engineering preferred), with 1–2 years of relevant experience.
  • Proficient in document control systems and software, such as Corel Designer, AutoCAD, SolidWorks, or similar tools, required to manage documentation and create standard operating procedures effectively.
  • Excellent attention to detail to ensure accuracy in technical drawings and work instructions.

Nice To Haves

  • Regulated Industries (e.g. FDA, ISO)
  • Danaher Business Systems (DBS)

Responsibilities

  • Develop, review, and maintain manufacturing work instructions to ensure they meet quality and regulatory standards.
  • Collaborate with engineers to revise and update existing work instructions to reflect design or process changes.
  • Maintain an organized database of current and historical manufacturing documentation.
  • Work closely with quality assurance, production teams, and other departments to ensure accurate documentation and facilitate process improvements.
  • Ensure all documentation aligns with internal quality systems and external regulatory requirements, such as FDA or ISO standards.

Benefits

  • Beckman Coulter Diagnostics, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives.
  • Whether it’s a health care program or paid time off, our programs contribute to life beyond the job.
  • Check out our benefits at Danaher Benefits Info.
  • We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

Stand Out From the Crowd

Upload your resume and get instant feedback on how well it matches this job.

Upload and Match Resume

What This Job Offers

Job Type

Full-time

Career Level

Entry Level

Education Level

Associate degree

Number of Employees

5,001-10,000 employees

© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service