Job Description Summary

Job Summary:
The Quality Specialist II is accountable for reagent product stability testing and microbiological testing as part of the QA Stability and Environmental Monitoring Program. The QA Stability Lab provides reagent product shelf life testing for new product introduction and ongoing shelf life studies for released products. The Microbiology Lab provides support to the manufacturing controlled non-classified areas and their routine environmental monitoring (which includes monitoring of the RODI and or compressed air system).

Routinely performs analysis of data and looks for trends. Develops, writes, and executes validation protocols to aggressively troubleshoot problem areas as indicated by data analysis. Normally receives no instructions on routine work. This person will work under minimal supervision on routine project and will have ability to take on increasingly complex task and responsibilities.

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. 

Job Responsibilities: (Primary Duties, Roles, and/or Authorities)

Functional Responsibilities:

• Perform reagent stability testing per procedure using flow cytometry and immunochemistry technique.

• Perform environmental monitoring for controlled non classified area, RODI systems, and bioburden testing.

• Routinely identifies and tracks microorganisms through characterization studies as they are found during RO/DI water monitoring, environmental monitoring, and bioburden testing.

• Performs trend analysis of viable and non-viable particle counts from environmental monitoring.

• Performs special projects as required such as shelf life studies per validation protocols, controlled non classified (CNC) qualification studies, preservative efficacy testing.

• Performs auditing as related to the RO/DI system, HVAC air handling system, and reference laboratories.

• Prepare data trending charts for routine Quality System Review and Management Review.  

• Raise adverse data and adverse trending to manage in a timely appropriate manner. 

• Evaluate adverse data and propose corrective action using the Quality Notification system.

• Author procedures, protocols, technical summary, and report with data analysis under guidance of senior staff.  

• Ability to progressively take on increasing complex technical writing.

• Troubleshoots equipment and takes responsibility for resolving these problems. 

• Maintains appropriate logs and documentation as necessary. 

• Escalates to management as needed for assistance.

• Creates purchase orders. 

• Orders supplies, prepares reagents, and assists with laboratory maintenance as required.

• Keeps abreast of the basic requirements 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 or issues to the attention of management.

• Performs other related duties and assignments as required.

Education and Experience:

• Requires a minimum of a Bachelor’s Degree in a biological sciences, microbiology, chemistry or related field

• Minimum 2 years relevant experience in a laboratory setting.

• Aseptic technique method for microbiological testing. 

• Knowledgeable with laboratory operations and maintenance of lab equipment.

Knowledge and Skills:

• Knowledge of applicable regulatory requirements.

• Class II / III medical device experience (preferred). 

• Knowledge of design control principles (preferred). 

• Ability to provide support to internal / external audits.

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

• Proficiency in written and verbal communication skills.

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. 

PDN

Primary Work Location

USA CA - San Diego (BDB)

Additional Locations

Work Shift

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 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 offered to a successful candidate is based on experience, education, skills, and actual work location. Salary ranges may vary for Field-based and Remote roles.

Salary Range Information

$77,100.00 - $127,200.00