POSITION SUMMARY:
An Associate Quality Scientist is responsible for independently managing the testing, technical transfer, and troubleshooting of protein-based immunoassays. An Associate Quality Scientist will play a critical role in addressing failing product, documenting failures appropriately and determining an appropriate path forward. This position may supervise the work of others directly and/or across interdisciplinary teams.
DUTIES AND RESPONSIBILITIES:
•Review testing data and perform analyses including investigations of failures, as well as process and product performance trending and monitoring.
•Provide descriptive statistical analysis using clear and concise methodologies and ensure accuracy and validity of data.
•Conduct experiments, summarize results, and present recommendations to cross-functional teams including senior management.
•Lead Material Review Board (MRB) meetings and facilitate discussions.
•Initiate, coordinate, and/or be the Technical Lead of CAPA documents (Deviations, Non-Conforming Material Report (NCMR), etc.).
•Establishes and monitors direct report performance and development goals, assigns accountabilities, sets objectives, establishes priorities, and provides continuous feedback and recognition on performance.
•Identify process and product improvements using product data and metrics as a guide.
•Ensure testing and process documentation complies with MSD processes. Develop, revise and implement Standard Operating Procedures (SOPs), Test Records, and product specification documents, as required.
•Participate in general lab organization including inventory and equipment management and support 5S compliance.
•Ensure application of laboratory safety precautions and proper use of personal protective equipment.
•Specific duties may vary based on departmental requirements.
EXPERIENCE AND QUALIFICATIONS:
•Bachelor's degree and 2 years of experience in relevant field is required.
•Additional education may be substituted for experience.
•Additional experience may be substituted for degree.
KNOWLEDGE, SKILLS AND ABILITIES:
•Strong understanding of protein-based immunoassays and technique.
•Knowledge of protein-based immunoassays execution, development, and optimization is preferred.
•Knowledge of laboratory safety precautions and proper use of personal protective equipment.
•Ability to troubleshoot immunoassays and reagents using logical problem solving and root cause analysis.
•Knowledge of Design of Experiments (DOE) is preferred.
•Execute solutions to improve product performance and articulate solutions to broad cross-functional teams.
•Demonstrated aptitude for learning and applying new techniques and methodologies.
•Understanding of basic molecular biology techniques and their application.
•Leadership skills with demonstrated knowledge and understanding of staff management practices and processes. Ability to establish accountabilities and expectations and manage performance to achieve results
•Ability to prioritize and manage multiple, complex tasks in a fast-paced environment under tight deadlines.
•Excellent oral, written communication and interpersonal skills are required.
•Effectively communicate issues/problems and results that impact timelines, accuracy and reliability of laboratory data.
•Proficiency in MS Office suite.
•Basic knowledge of standard data analysis tools and databases.
•Familiar with Matlab, MiniTab or other statistical software analysis tools is preferred
PHYSICAL DEMANDS:
•This position requires the ability to communicate and exchange information, utilize equipment necessary to perform the job and move about the office.
WORK ENVIRONMENT:
Standard office environment.
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