Senior Chemist

Benefits: 401(k) 401(k) matching Dental insurance Health insurance Paid time off Vision insurance The Senior Chemist performs testing of samples in the product fulfillment process according to FDA and other applicable regulatory standards, participates in investigations related to QC processes or data, trains QC employees, troubles shoot methods and processes, performs testing of samples, maintains and troubleshoots testing equipment. Serves as the primary link between the QC team and the QA facilitator, for day-today activities, such as schedules and workload planning, coordinates workflow in QC team, verifies QC data, while monitoring for trends and abnormalities. Performs project work, and leads laboratory investigations, develops methods and processes. DUTIES & RESPONSIBILITIES: The following responsibilities would characterize the requirements of this position. Must possess the skills necessary to perform the majority of the listed functions: Review and approve the documentation setting forth the basis for qualification of any supplier. Performs project work, and participates in investigations Trains QC employees in GMP, QC methods and processes Troubleshoots methods and processes Serves as an expert in a specific area of laboratory equipment, process or system Enter and review data and other analytical equipment as appropriate May serve as the primary link between QC team and QA Facilitator Complete final review and approval of product specifications, production batch records, laboratory raw data, labels, and COAs for raw materials and finished products Send laboratory releases to customers Monitor and track instrument calibrations and preventative maintenance Coordinates workflow in QC team, directs priorities and testing schedules Verifies and approves QC data, while monitoring for trends and abnormalities. Reports, and acts on data results Serves as QC lead for investigations in process areas, related to QC processes or data, such as sampling, deviations potentially affecting QC results, investigational sampling and testing Assist the Director of Quality to complete internal Lab audits to ensure policies and regulations of FDA (cGMP), TDA, third party certifiers and internal SOPs are followed Develops and validates new Lab methods Serves as primary contact for contract services, including laboratory testing Serves as the technical leader in the laboratory Serves as the main contact for issues as they arise, and aid/direct troubleshooting activities when appropriate Main point of contact for finished product testing Main point of contact for raw material program Acts as a leader in the laboratory through display of leadership capabilities Aid in the development of chemists through mentoring and training. REQUIREMENTS: Competencies Master's degree in Chemistry, Chemical Engineering, Biochemistry, or a related field is required A Ph.D. or post-doctoral experience is strongly preferred Hands-on experience with High-Performance Thin-Layer Chromatography (HPTLC) and High-Performance Liquid Chromatography (HPLC) machinery is a plus Strong background in Food Science is highly desirable This wording highlights the educational requirements, technical skills, and specific focus areas needed for the role. Internal and External Contact/Customers Working knowledge of Microsoft office and general computer concepts Ability to demonstrate effective leadership skills Ability to follow GMP and SOP guidelines Good written and verbal communication skills and problem-solving skills Good organizational skills with a strong attention to detail Ability to multi-task and prioritize responsibilities Ability to work both independently and in a team environment

Created: 2024-11-05