Quality Document Clerk – LMS Coordinator
Job Description Summary
Job Description
Be part of something bigger!
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
The Quality Document Clerk – LMS Coordinator is accountable for Quality Control, maintenance and compliance to applicable Quality Systems. This position actively participates in quality guidance, product resolution decisions and statistical problem-solving techniques. The Quality Associate Clerk reports to the Quality Supervisor and/or Quality Manager.
Key responsibilities will include:
Implement and monitor all procedures and processes as they relate to Quarantine, Hold, Expired, Damages, Return Goods and Recalled product
Ensures the accurate and meaningful product hold and quarantine processes and records for the making of decisions.
Ensure compliance to Document and Record Control procedures.
Responsible for assuring products are reworked, labeled, stored and distributed in a manner that meets their product requirements and prevent unsaleable conditions prior to shipment to customers
Collaborates with functional process owners to train, mentor and/or facilitate QMS requirements and continuous improvement.
Accountable for Quality System as the local Subject Matter Expert (SME), providing guidance and training, facilitating meetings, critical issue and ensuring compliance to Quality Systems as assigned (Returns, Rebox, Document and Record Control, Training & Curricula / C2C DLA, Non-Conformance Management)
Scrap material as appropriate, following all applicable procedures and disposal process, including Hazwaste requirements
Share best practices and tools to accelerate continual quality improvement into DC organization locally and across the region, initiating lessons learned and best practice concepts; to introduce pro-active improvement and prevent recurrence of issues.
Create and maintain documents in accordance with the Document Control Procedure, Work Instructions, Regulatory Compliance documentation, corrective action and other related forms and records.
About you:
Excellent communication, problem solving, organizational and interpersonal skills are essential.
Ability to understand FDA, EPA, DOT and OHSA rules and regulations
Self-motivated and directed, requiring minimal direction
Proven ability to work in teams to obtain results is required.
Effective skills in analytical thinking and problem solving required
Participate in internal/external quality audits and report findings.
Duties include creating monthly management reports, including internal and external reports.
Provide assistance to Team Lead, Quality Supervisor and/or Manager to research and create detailed reports when required.
Education and experience required:
A minimum of 3 years relevant experience in Quality, Supply Chain and/or Distribution Center operations, preferable in Medical Device and/or Pharmaceutical regulated industry
Working knowledge and application of ISO 13485 and 21 CFR 820 preferred
MS Office competency (Excel, Word, Power Point, etc.)
Hazardous Materials, RCRA training is preferred
Click on Apply if this sounds like you!
Why join us?
A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
To learn more about BD visit https://jobs.bd.com/
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
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Primary Work Location
USA IN - PlainfieldAdditional Locations
Work Shift
US BD 1st Shift 8am-430pm (United States of America)Recommanderà un ami
Approbationdu Présiden et Chef de la direction
«Nous sommes une entreprise qui vise des résultats concrets et où nos associés s’emploient chaque jour à améliorer les soins de santé. De nombreuses initiatives sont en cours pour faire de BD un leader mondial des technologies médicales.»
Anonyme, Franklin Lakes, NJ
