Job Description

Job Description

The QM Associate Scientist is a laboratory Microbiologist who independently schedules and performs a wide variety of multiple, sophisticated microbiological tests of biological raw materials and greater than 100 different products in response to customer demand. Performs data analysis using visual, instrumented, graphical and calculative means based on the biochemical, selectivity and growth promoting properties of media. Assures that documentation and procedures are followed, updated and maintained as required by internal Quality Policies and related FDA/GMP guidelines. Performs non-routine detailed project support and investigational testing and is involved in resolution of technical issues related to microbiological processes. Daily use of personal protective equipment (e.g. respirators, gloves, etc.). Willing to Cross train in other sections of the Quality Laboratories for surge events and as needed. Ability to train other personnel on appropriate test methods and techniques thoroughly, as needed.

The QM Associate Scientist may be required to perform testing of Mycobacterium tuberculosis (TB) and other similar organisms requiring Biosafety Level 3 Laboratory containment with strict adherence to safety policies associated with this manner of testing.

Knowledge and skills:

Experience working with Microbes and Bacteria and associated knowledge of a biosafety level 2 laboratory.
Knowledge of Microbiology and Biochemistry as they relate to bacteria, yeast, and fungi.
Ability to work in a clean room environment meeting validation requirements associated with donning and doffing clean room garments.
Knowledge of the following industry regulations FDA (Food and Drug Administration), GMP (Good Manufacturing Practice) / QSR (Quality System Regulation), ISO (International Organization of Standardization).
Knowledge of cGMP (Good Manufacturing Practice) and In-depth understanding of good documentation practices in a GMP environment.
Knowledge of PC spreadsheet, word processing, and database applications.
Excellent verbal and written communication skills.
Good problem solving and trouble-shooting skills with the ability to make independent decisions.
Multilevel profile access to SAP Quality module is helpful.
To be successful in this position you must possess: patience, attention to detail, decisiveness. independence, excellent IT skills, numerical and analytical skills.

Education

Bachelor's Degree in Biology, Microbiology or other related Life Science is required with 1-3 years practical experience in a Microbiological, or Medical Technology Laboratory.

Proficient Working Skills

Isolate and maintain cultures of bacteria or other microorganisms such as algae, fungi, and some types of parasites, of both pathogenic and non-pathogenic abilities. Record, analyze and interpret data, while ensuring that data is recorded accurately in accordance to guidelines. Ability to resolve causes of process or testing errors and deciding what to do about it with some supervision. Conducting microbiological tests and inspections of products, services, or processes to evaluate quality or performance. Ability to work with microscopes, analytical balances, biological safety cabinets and filtration manifolds. Able to implement sterile technique and good lab practices.

Position is subject to extended periods of sitting, and standing, frequent walking, and occasional lifting of materials weighing 25-50 pounds. Must exhibit the Becton Dickinson Core Values to do what is right, take personal responsibility, anticipate and address the challenges of patients and customers globally, as well as innovate and improve continuously, and respect, collaborate, challenge and care about each other.