Job Description Summary

Job Description

We are the makers of possible 

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

Summary:
This position is primarily responsible for review and release of all manufactured product and incoming materials, status labeling, and sampling plan management.  This position will manage the sample retention program, and accurate SAP accounting of retention and stability samples.  This position will own procedures within scope of primary duties.  Responsibilities include DHR review, completion and filing, analysis of results, determining and executing disposition of manufactured product and incoming materials, status labeling, aiding in investigation of nonconforming conditions and complaints, managing nonconforming material disposition, and accurately recording and reporting quality data for manufactured product.  This role will perform back-up duties for incoming inspection, line verification and quality inspection / quality control on the reagent manufacturing production lines, as needed.  This role is responsible for working within an established framework of compliance and developing and implementing improvements to product quality and the quality system.

Responsibilities:

• Review Device History Records for compliance to instructions including deviations or protocols and analyzing inspection results vs. specifications.  
• Ensure accuracy and completeness of documentation, use of correct sample plans, materials utilized are released and correctly accounted for, and equipment used meets designated specifications, including calibration.
• Update material disposition status in SAP (including release of materials for production, and for distribution to customers), and ensure accurate status labeling applied.
• Detect nonconforming conditions during review and accurately document each condition.
• Demonstrate a bias for action to determine scope of nonconforming conditions and segregate nonconforming products to prevent further use.
• Develop and recommend actions to address nonconforming conditions or processes.
• Initiate Quality Notifications as required for manufactured product or incoming parts.
• Assist in investigations of nonconforming product or customer complaints as required. 
• Complete required electronic and hard copy filing of Quality Records.
• Maintain Sample Retention Program and maintain state of 5S in retention room area.
• Maintain accurate procedures within scope of role. 
• Develop and implement process improvements within own area and work effectively with teams to identify and develop process improvements. Participate in Kaizen or other Continuous Improvement efforts.
• Must perform work in a safe manner adhering to gowning and PPE procedures.
• Handle hazardous materials as appropriate.
• As a back-up when required:
  • Independently perform and document final inspection of all production slides, vials, kits and labels to established quality specifications, and make independent determination of acceptability for release.
  • Perform incoming inspection activities as a back-up when required.
• Additional responsibilities as assigned by QA management.

Qualifications:

• High School Diploma/GED with a minimum of 4 years QC or manufacturing experience. An associate degree in quality, science, or engineering related field may be equivalent to 2 years’ experience.
• Minimum of 2 years’ experience in a Quality Assurance role within a current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), or medical device company.
• Experience working in SAP is preferred.
• General Proficiency in Microsoft Office
• Demonstrated understanding of sampling techniques and inspection standards.
• Basic math skills and the ability to utilize Excel for basic calculations and graphing.
• Must be able to speak, read, and write English fluently as well as write technically and summarize information into data reports using Microsoft Word.
• Excellent attention to detail with a high degree of accuracy and the ability to work independently and in team situations.
• Excellent observation skills with a bias for “corrective action” and improve work environment processes and procedures.
• Demonstrated ability to make critical decisions regarding product quality or quality system compliance.
• Ability to assess and articulate risk when evaluating a situation.
• Knowledge of basic validation, equipment calibration, and change requirements.
• Demonstrated understanding of the use of calibrated equipment.
• Proven capability to prioritize responsibilities and complete tasks on schedule.
• Must be able to work independently in a fast-paced manufacturing environment.
• Ability to stand for long periods of time.
• Ability to lift 25 lbs.
• Ability to do repetitive motion.

Work Environment:

• Associate must be present at designated shift start-up times to ensure smooth production operation.
• Schedule may need to flex based on business needs that require nontraditional work hours
  (10-hour shifts / 4 days per week).
• Ability to periodically work overtime as production needs require.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.  

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.  

To learn more about BD visit https://bd.com/careers

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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