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. 

Responsible for conducting quality analysis of bulk, in-process and finished goods under limited or no supervision and according to standard operating procedures. The Quality Scientist III should demonstrate proficiency in all applicable QC techniques, operation of relevant equipment and software packages associated with testing, data analysis, interpretation and reporting. Designs and performs troubleshooting, investigations, provide and follow corrective/preventive actions for failures and non-conformances. The Quality Scientist III should identify potential problems, bring them to the attention of supervisor, analyze them, and get them resolved.

Duties and Responsibilities:

• Performs bulks in-process or finished goods, QC testing following analytical methods and procedures (such as Flow Cytometry, HPLC, ELISA, Spectrophotometry, etc.) for products

• Review device history records as assigned. Performs investigation for atypical or Out of Specification (OOS) results and makes recommendations as appropriate. Writes, reviews and approves OOS and Quality Notification (QN’s) as appropriate

• Provide technical guidance to resolve issues and follow-up on actions

• Assures bulk and/or finished products conform to established specifications

• Support complaint investigations and provide guidance on QC techniques to complaint investigators

• Assures calibration, maintenance and cleaning of equipment and instrumentation. Maintains related logs and records

• Coordinate and assign tasks among laboratory personnel in alignment with production schedules and ensures compliance

• Assists in development and evaluation of new procedures and techniques as assigned and analyzes in detail existing methods to suggest improvements. Perform Engineering Change Orders (ECO) as needed

• Assist in the technical training of less experienced personnel and provides guidance on troubleshooting

• Lead and execute QC Continuous Improvement projects and communicate project status

• Lead QC technical transfer activities, such as new test method implementation, execution of pilot and validation runs for applicable QC methods

• Perform material transactions on SAP system

• Informs direct supervisor of developments that may affect operations or contribute to personnel issues, incidents or accidents

• Keeps abreast of the basic requirements for compliance in own area of work and aligns with those requirements.  Participates as required in training on regulatory issues affecting own area of work.  Brings regulatory compliance questions/issues to next level of management

• Promotes a safe work environment. Should provide recommendations on maintaining the safety of the work environment.  Participates in Environment Health and Safety programs. Addresses corrective/preventive actions whenever a hazard is identified. Notifies supervisor of all observed hazardous conditions or unsafe work practices

• Carries out the assigned direct supervisor responsibilities during his/her absence

• Lead and actively participate in the Lean Daily Management System by attending, leading shift start up meetings, and providing appropriate status follow up

• Lead QC continuous improvement initiatives for product/process quality and enhance productivity, reduce cost, and increase production capability

• Maintain QC metrics and present status to management

• Performs other related duties and assignments as required

Knowledge and Skills:

• Expertise and working knowledge in the operation of related instrumentation such as Centrifuges, Biohoods, HPLC, Spectrophotometer and Flow Cytometers. Experience training other individuals in use of the instruments

• Ability to conduct laboratory investigations for out-of-specification results and other quality notifications

• Proficiency in all applicable QC techniques and software packages associated with testing, data analysis, interpretation and reporting

• Demonstrated proficiency and ability to troubleshoot immunoassays related to cell biology applications: Cells immunophenotyping, ELISA and Western Blots

• Use of MS Windows and MS Office, database and information management systems.

• Knowledge of GMP, FDA, ISO and OSHA requirements highly desirable

• Proven troubleshooting skills for equipment assigned

• Effective skills on analytical thinking, problem solving, interpersonal skills, written, and oral communication

• Effective project management and planning/organization

• Effective presentation skills

• Demonstrated ability to follow established policies and procedures

• Fully Bilingual (English and Spanish).

• Willing to travel to US mainland and offshore

Education and Experience:

• Requires a Bachelor Degree in a related scientific field (such as Chemistry, Biochemistry, Biology, Microbiology or Medical Technology)

• Minimum of six years of experience in a pharmaceutical / medical device / biotechnology environment and / or medical technology laboratory

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

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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