Quality Control Raw Material Supervisor Position Available In Madison, Alabama

Quality Control Raw Material Supervisor TriRx Shawnee LLC Huntsville, AL Job Details Estimated:

$83K – $115K a year 1 day ago Qualifications Microsoft Word Laboratory procedures CGMP Microsoft Excel GLP Doctoral degree Laboratory experience GMP Microsoft Office Doctor of Chemistry Profit & loss Project management Bachelor’s degree Doctor of Philosophy Technical writing Chemistry Manufacturing Root cause analysis Senior level Leadership 2 years Lean manufacturing Negotiation FDA regulations Full Job Description Job Summary – a concise overview of the job A Raw Material Supervisor provides team leadership in the day-to-day activities of the Raw Material department. Directly supervises raw material chemists in the ongoing effort to support the production schedule and product quality requirements. Develops and implements quality excellence activities and identifies and executes continuous improvement opportunities for the department. Utilizes established methods and procedures and laboratory equipment to perform the analytical testing and ensure all products released are safe and efficacious. Develops, performs, and summarizes method transfer and validations, and conducts laboratory investigations. This is a working supervisor position, as the individual will still perform analytical duties as needed. This individual will need to be able to adjust planning and schedules as needed, to support a dynamic production schedule. Scope of Authority – span of control (work unit, site, department, division, etc.) , monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc. The Raw Materials Supervisor operates within the Analytical Quality Control Laboratory, under the direction of the Quality Organization. The Raw Materials Supervisor has no budget/spend authority, but acts as SME in the selection of materials and equipment. Key Accountabilities – key outcomes/deliverables, the major responsibilities, and % of time Accountability Responsibilities % of Time Floor Operations Maintain an organized database of raw material testing and history in order to ensure annual material quality commitments are maintained Schedule day-to-day activities of analysts in the raw materials department Oversee Laboratory Technician(s) to ensure the analytical laboratory maintains an adequate stock of consumables and reagents to support commercial activities. Represent the raw materials group in cross-functional activities, assessing impacts to the team and identifying gaps in support Represent Quality Control, as needed, for raw material specific requests and queries by clients. Attend client tag-ups as needed to provide support for raw materials. Work closely with other internal departments, such as Scheduling, Purchasing, and Operations to ensure the QC Lab has adequate resources and availability to support the production schedule. Creates, develops, and executes protocols for method transfers, method validations. Coordinate transfers (with Analytical Tech Services) for raw materials moving to a commercial status. Conduct and perform investigations for analytical events. Multitask projects while maintaining high levels of accuracy Perform other duties as assigned 60% Non-Conforming Events Complete complex laboratory investigations with a thorough understanding of root cause analysis and required CAPAs. Be able to fully complete and document NCRs / Events, and assign associated risk levels. 20% Process Improvement Work in cross functional teams as necessary to complete projects, transfers, and investigations. Function as laboratory representative for facility and company-wide initiatives. Act as the Quality Control liaison for specific projects and the associated clients. 20% Compliance Maintain current training compliance on assigned SOPs and company policies. Accurately and legibly document and record all work completed so that analyses may be fully traceable and reproducible. Be familiar with operation of all lab equipment, as the raw materials group utilizes all equipment in the lab Complete department trend reviews and analyses. continuous Safety Operate under all corporate safety requirements at all times, including use of PPEs and adherence to company policies in handling of hazardous substances continuous Total 100% Qualifications Education & Experience Minimal acceptable level of education, work experience and certifications required for the job Bachelor’s degree in Chemistry or Related Field, with a proven ability to display aptitude for all the tasks under Responsibilities, or pH.D. in Chemistry or Related Field, with a minimum of 2 years’ experience in an analytical laboratory. Knowledge Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc. Knowledge of FDA regulations Familiarity with Good Manufacturing Practices (GMPs) Familiarity with analytical laboratory operations and associated safety requirements Possess a solid understanding of column chemistry with ability to troubleshoot most problems without support. Root Cause Analysis Skills & Abilities Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc. Experience with chromatographic equipment and integration software Experience with Microsoft Office Suite of Products, including Word, Excel, and Teams Analytical laboratory experience Project Management Physical Requirements Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc. Must be capable of wearing all appropriate PPEs correctly during handling of hazardous substances Some work may require extended periods of time standing at a lab bench Must be visually capable of accurately measuring and reading volumes of solution in volumetric apparatus (i.e. accurately read meniscus)