The QM Scientist is a laboratory Microbiologist who is primarily responsible for Quality Control testing of prepared media against acceptance specifications. The QM Scientist is responsible for managing the day to day operation of the Quality Control Laboratory as it relates to microbiology processes within the Biosafety Level 2 and Level 3 laboratories, is responsible for product release, scheduling of staff and assuring documentation and procedures are followed, updated and maintained as required by internal Quality Policies and related FDA/GMP guidelines. The QM Scientist conducts product testing, complaint investigation, special investigative testing, assists in the investigation of manufacturing issues and provides data and input on technical issues and projects.
The QM Scientist is required to perform testing of Mycobacterium tuberculosis and other similar organisms requiring Biosafety Level 3 laboratory containment with strict adherence to safety policies associated with this manner of testing. Associates must pass an FBI background check along with other internal program requirements.
The QM Scientist is responsible for assisting in the development of experiments or test methods, execution of experiments or test methods, analysis of results and interpretation/reporting of results. Will present scientific results to others orally and in writing and prepare/submit technical documents for external presentations/publications. The QM Scientist is part of a cross functional team working with technical support of manufactured products, process and/or supplier quality, media formulation and supporting technology transfers.
MINIMUM QUALIFICATIONS :
KNOWLEDGE AND SKILLS:
- Experience working with Mycobacterium tuberculosis and associated knowledge of a biosafety level 3 laboratory.
- Must have knowledge of Microbiology and Biochemistry process 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).
- Knowledge of PC spreadsheet, word processing, and database applications.
- Good verbal and written communication skills.
- Good problem solving skills with the ability to make independent decisions.
- Must pass an FBI background check along with other internal program requirements.
- Multilevel profile access to SAP Quality module is preferred.
Bachelor's Degree in Biology, Microbiology or other related Life Science is required.
1-2 years of work experience in an R&D or Quality Control Laboratory and experience working with Mycobacterium tuberculosis preferre d . Management of the day to day operation of a microbiology or similar laboratory preferred.
- 2 years ago - save job