Be part of something bigger at BD. Here, you’ll help us continually improve how we do things every day; to be more efficient, more effective and better serve our customers. You’ll do this within an exceptional team all striving to make sure that everything we do complies with regulations and standards, not just because it’s the right thing to do, but because our products impact people’s quality of life. Here, you’ll put your compliance experience, high expectations and attention to detail to the very best use: advancing the world of health™. At BD, you can make a true difference of one.
Job Description SummaryThe Quality Clerk 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.
- Implement and monitor all procedures and processes as they relate to Quarantine, Hold, Expired, Damages, Return Goods and Recalled product
- Ensures the accurate and actionable 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, escalation and ensuring compliance to the following Quality Systems as assigned:
- 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.
- 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.
- Damage Subject Matter Expert, providing feedback to DC personnel on damage standards and training as needed.
- Process sample requests from the business units
- Complete return and rework (rebox) processing per procedure, if applicable
- Other duties as assigned
** Must be able to work night or weekend shifts**
- A minimum of 5 years relevant experience in Quality, Supply Chain and/or Distribution Center operations
- High School diploma required
- Computer skills (Excel, Word, Power Point, etc.)
- 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 supervision
- Demonstrated ability to work in teams to obtain results is required.
- Effective skills in analytical thinking and problem solving required
- Associate Degree preferred
- Experience in Medical Device and/or Pharmaceutical regulated industry preferred
- Working knowledge and application of ISO 13485 and 21 CFR 820 preferred
- Hazardous Materials, RCRA training is preferred
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.
Primary Work LocationUSA NC - Four Oaks
What makes a successful Quality Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.
Advancing the world of health™
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. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.
BD is unique in how fully dedicated it is to a specific disease state. It makes it clear how the work we do directly impacts the daily lives of the patients we serve.
Senior Director Quality Management
To know that our products touch 30 million people with diabetes around the globe is powerful and fuels our teams to deliver best in class products to them each and every day.
It is inspiring to see BD products to be used globally to advance human healthcare.
Manager Medical Laboratory