Quality Associate Scientist

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. They perform data analysis using visual, instrumented, graphical and calculative means based on the biochemical, selectivity and growth promoting properties of media. Additionally, the QM Associate Scientist ensures that documentation and procedures are followed, updated, and maintained as required by internal Quality Policies and related FDA/GMP guidelines. They also perform non-routine detailed project support and investigational testing and are involved in resolving technical issues related to microbiological processes.

Responsibilities

- Independently schedule and perform a wide variety of complex microbiological tests. - Perform data analysis using various methods. - Ensure compliance with internal Quality Policies and FDA/GMP guidelines. - Conduct non-routine detailed project support and investigational testing. - Resolve technical issues related to microbiological processes. - Sit for extended periods, stand frequently, walk occasionally, and lift up to 50 pounds. - Use personal protective equipment as required. - Cross-train in other sections of the Quality Laboratories for surge events and as needed. - Train other personnel on appropriate test methods and techniques. - Exhibit the client Core Values: do what is right, take personal responsibility, anticipate and address the challenges of patients and customers globally, innovate and improve continuously, and respect, collaborate, challenge, and care about each other. - Perform testing of Mycobacterium tuberculosis (TB) and other similar organisms requiring Biosafety Level 3 Laboratory containment, adhering to safety policies.

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. - Knowledge of 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 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. - Patience. - Attention to detail. - Decisiveness. - Independence. - Excellent IT skills. - Numerical skills. - Analytical skills. - Teamworking skills.

Qualifications

- Bachelor's Degree in Biology, Microbiology, or other related Life Science is preferred OR a certificate of laboratory techniques or medical laboratory technology from an accredited certificate program combined with 2 years + of relevant experience working in a microbiology laboratory. - Preferred 1+ years practical experience in a Microbiological or Medical Technology Laboratory.

Skills

- Knowledge of 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 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. - Patience. - Attention to detail. - Decisiveness. - Independence. - Excellent IT skills. - Numerical skills. - Analytical skills. - Teamworking skills.