Performs visual, dimensional and functional inspections on a wide variety of products in accordance with internal procedures and Product Specifications. Reports non-conformances to Supervisor and discusses corrective action. In addition, follows-up to see if corrective action was effective. Determines whether product is acceptable or rejected, initiates rejection notices, and maintains accurate written records of the inspections performed, including the results. Recognizes conditions outside their specific areas of inspection which require action and refers the items to the supervisor. Monitors compliance to G.M.P. in employee working areas and reports infractions to Q.C. Supervisor for corrective action. Employee evaluates both the product and process, making decisions on subjective visual inspections. Responsibilities have an impact on product quality, productivity, and product costs as affected by internal and external costs of rework, scrap and product warranty.
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. The QM Associate Scientist performs data analysis using visual, instrumented, graphical and calculative means based on the biochemical, selectivity and growth promoting properties of media, In addition, the QM Associate Scientist assures that documentation and procedures are followed, updated and maintained as required by internal Quality Policies and related FDA/GMP guidelines. The QM Associate Scientist performs non-routine detailed project support and investigational testing and is involved in resolution of technical issues related to microbiological processes. The QM Associate Scientist is subject to extended periods of sitting, and standing, frequent walking, and occasional lifting of materials weighing 25-50 pounds. The QM Associate Scientist must be able to use personal protective equipment (e.g. respirators, gloves, etc.). The QM Associate Scientist must be willing to Cross train in other sections of the Quality Laboratories for surge events and as needed. The QM Associate Scientist must be able to train other personnel on appropriate test methods and techniques thoroughly, as needed. The QM Associate Scientist must exhibit the 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.
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. Associates must pass an FBI background check along with other internal program requirements.
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 preferred.
• Attention to detail
• Excellent IT skills
• Numerical skills
• Analytical skills
• Teamworking skills
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.
• 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.
• Recording, analysing and interpreting data, while ensuring that data is recorded accurately in accordance to guidelines.
• Ability to Determine 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.
• ablity to work with microscopes, analytical balances, biological safety cabinets, filtration manifolds, and must be able to adhere to sterile technique and good lab practices.