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. 

Supervisor, Quality Assurance Laboratories
The Supervisor of Quality Assurance Laboratories is responsible for the daily activities of the QA Stability and Microbiology laboratories. This position provides direction to staff working in laboratory functions including environmental monitoring, microbial characterization, and stability testing for product shelf-life determination. The supervisor will be accountable for all activities within their lab area(s), which may include but are not limited to lab/bench work, training, scheduling, coaching, performance management, and addressing employee concerns.

Responsibilities:

• Supervisory and leadership position – manage, train, mentor, and coach junior associates and direct reports.

• Manage the activities of the Stability and Microbiology Laboratories. New Production Introduction:  

• Provide support to perform lab experiments for stability studies and/or environmental monitoring test as needed

• Provides critical quality engineering direction to projects with respect to generally accepted quality engineering tools/principles, such as root cause analysis, FMEAs, risk mitigation, validation, DOE/other process improvement tools, measurement and measurement systems analysis, sampling, and control plans. 

• Act as QA core team for key NPI projects.

• Responsible for assuring that contamination control and environmental control processes are implemented and effective and that regulatory compliance issues are thoroughly addressed.

• Maintain the stability studies schedule and assign studies to the appropriate staff and ensuring completion.

• Maintain the environmental monitoring program, assigning testing to the appropriate staff, ensuring completion.

• Author procedures, protocols, reports, and technical summary for stability studies and CNC (controlled non classified) qualification studies.

• Prepares reports, including quantitative / qualitative analysis, summaries, and protocols. 

• CNC qualification includes (but not limited to) cleanability, disinfectant evaluation, construction or facility modification which include HVAC, equipment introduction or maintenance within CNC.

• Act as site’s point of contact for environmental control area (for example CNC operation) and can set propose CNC policies, guidance, and procedures to support Operations. 

• Establishes a strong working and collaborative relationship with all levels of operations, R&D, Regulatory Affairs to provide the appropriate support for stability studies, CNC operation, and regulatory notification or submission.

• Reviews data obtained from testing and monitors for compliance to specifications, SOPs, WIs, and cGMP requirements.

• Reports abnormalities or non-compliance to the appropriate resources and works with a team to determine path forward.

• Reviews and approves test reports.

• Additional responsibilities maybe evaluated and or added, based on business and quality needs. 

• Performs other tasks assigned by management as required.

• Revises policies/procedures. 

• Prepares reports, including quantitative / qualitative analysis, summaries, and protocols. 

• Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions to problems with broad scope and complexity.

• Participates in internal regulatory audits (FDA, notified body) as SME for all cleaning and CNC areas. 

• Assists in preparing response to internal and external audits.

Qualifications

Education and Experience:

• Requires a Bachelor’s Degree in Science or related field.

• A minimum of 4 years in Quality Engineering with strong background in new product introduction, stability study, statistical analysis, and validation. 

• Experience with flow cytometer and understanding flow data required

• Strong technical writing skills is required, experience with writing technical documents, protocols, and reports for stability studies and CNC qualifications.

• Experience with interacting with external auditors (FDA, BSI, and USDA) preferred

• ASQ Certified Quality Engineer, Reliability Engineering, or equivalent (preferred) to support trending of data from Environmental Monitoring and stability studies.

• Knowledge with water process systems and compressed air systems preferred

Knowledge and Skills:

• Knowledge of applicable regulatory requirements.

• Knowledgeable with ISO 9001, ISO 13485, ISO 14971, ISO 14644.

• Breadth of knowledge in design control, risk management

Skills

• Class II / III medical device experience (preferred).  Knowledge of design control principles (preferred). 

• Proficiency in Minitab or other statistical software, MS Excel, and MS Word required. 

• Proficiency in written and verbal communication skills. Demonstrate interpersonal skills to create a collaborative working relationship among cross function partners.

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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At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.

Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.

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