Job Description Summary

The Quality Scientist II is responsible to apply basic scientific principles to routine laboratory work and for gaining experience in the application and interpretation of the department procedures. The QSII act as a group leader, assigning daily/weekly/monthly task, monitoring work completion, driving schedule compliance and serving as liaison with upper management. Will perform assigned routine laboratory tasks and learn the application of Quality procedures to ensure compliance. Works with SAP enterprise system to enter laboratory data, update documents, and enter process non-conformance investigation summaries. Implements changes and improvements and participates in intra-departmental teams. Ensures documentation compliance and processes documentation.

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. 

The Quality Scientist II is responsible to apply basic scientific principles to routine laboratory work and for gaining experience in the application and interpretation of the department procedures. The QSII act as a group leader, assigning daily/weekly/monthly task, monitoring work completion, driving schedule compliance and serving as liaison with upper management. Will perform assigned routine laboratory tasks and learn the application of Quality procedures to ensure compliance. Works with SAP enterprise system to enter laboratory data, update documents, and enter process non-conformance investigation summaries. Implements changes and improvements and participates in intra-departmental teams. Ensures documentation compliance and processes documentation.

Performs a variety of assignments within the QC lab as a group leader and point of contact, in support of assigned plant operations to ensure the highest standards are met for products. This includes testing of raw materials, work in progress and finished goods using a variety of testing techniques.

Responsibilities

• Performs general laboratory duties (i.e. quality control checks on reagents, lab cleaning, etc.) as directed by departmental SOPs.

• Handles hazardous materials, including chemicals and infectious agents in the proper manner as established by safety and company policy.

• Orders and prepares reagents, materials, formulations, laboratory supplies and equipment and maintains sufficient inventories so as to prevent delays in project schedules.

• Assists in documentation writing & revising including test methods, final product specifications, SOPs, etc. as required.

• Reviving freeze dried cultures, ordering cultures, maintaining cultures including aerobic, anaerobic, mycobacteria and fungal, splitting and freezing cultures, determining culture cell concentration.

• Use MacFarland standard for cell counts

• Culture verification using gram staining and colony morphology

• Maintaining culture database, lineage and history internally

• Taking the lead role in troubleshooting process and equipment problems

• Recommending equipment, supply purchases within the production areas

• Developing creative solutions to operational problems by leveraging knowledge of available theories and proven solutions

• Performs data entry on material being tested (where required).

• Understands and complies with company GMP, ISO and Safety Policies and Procedures.

• Identifies problems and looks for ways to solve them (Continuous Improvement)

• Manages time efficiently, and is able to re-order priorities as needed

• Able to delegate tasks to lab associate appropriately

• Possesses the appropriate interpersonal and communication skills to effectively interact with all areas both inside and outside the corporation.

• May be expected to make presentations

• Undertakes additional duties as assigned

Qualifications

• Some prior knowledge of regulatory, corporate or business required

• Supports the QA release laboratory activities including; set-up o