QM Associate Scientist
MillenniumSoft Inc · Hunt Valley, MD · 23 mo ago
Information TechnologyFull-time
About the role
The QM Associate Scientist is a laboratory Microbiologist who independently schedules and performs a wide variety of multiple, complex microbiological tests of complex biological raw materials and greater than 100 different complex products in response to customer demand.
Responsibilities
- Performs data analysis using visual, instrumented, graphical and calculative means based on the biochemical, selectivity and growth promoting properties of media.
- Affirms 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.
- Subject to extended periods of sitting, and standing, frequent walking, and occasional lifting of materials weighing 25-50 pounds.
- Must be able to use personal protective equipment (e.g. respirators, gloves, etc.).
- Must be willing to cross-train in other sections of the Quality Laboratories for surge events and as needed.
- Must be able to train other personnel on appropriate test methods and techniques thoroughly, as needed.
- 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.
Requirements
- 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.
- Attention to detail
- Decisiveness
- Independence
Skills
- Excellent IT skills
- Numerical skills
- Analytical skills
- Team working skills
Qualifications
- Bachelor's Degree in Biology, Microbiology or other related Life Science is required with 0- 1 years practical experience in a Microbiological, or Medical Technology Laboratory.