QC Supervisor

TFA Staffing Co. is a full service professional staffing agency. We specialize in the High Technology profession with talent in many different areas. A faster pace - The average professional at TFA Staffing completes 8 to 12 engagements in a year across numerous areas of practice and client industries. Large Enterprise Clients: Our consultants work on critical projects for some of the world's largest companies. We have a diverse set of clients with an emphasis in Professional and Executive Level, Financial Services, Information Technology, Health Care, Sales, Engineering, Industrial and Skilled Labor. We offer candidates complete confidentiality in their search and provide employers with simple, targeted searches from a database of qualified candidates through partnerships with affiliate companies. Job Description Full-Time Pharmaceutical in Shawnee Mission, Kansas, United States Oversees and supervises the full daily laboratory operations to maintain regulatory compliance and meet customer needs. Serves as Departmental Manager in the absence of the Manager. Collaborates with the client\'s R&D in the development, validation and transfer of new analytical test methods required for a wide variety of materials, many of which require state-of-the-art methodology. Supervises preparation of associated scientific documents and reports. Approves test methods, method validation, and transfer reports. Directs departmental staff through the Daily Operations Team Leader to assure analyses for customers meet requirements to avoid delays. Directs analysis of raw materials, preliminary formulations, process development and validation samples for new formulations and storage stability samples; provides stability data to the Pharmaceutical Quality Control Stability group. These data support FDA, EPA registrations and international registrations and help establish expiration dates for drugs. Assists the Manager in developing and adhering to the departmental annual budget and in achieving departmental and divisional goals. Supervises, trains, motivates and develops personnel working in the lab area; provides opportunities to attend professional meetings to improve technical knowledge. Leads the client\'s Quality Improvement Process in Pharmaceutical Analysis. Enforces guidelines to comply with government regulations such as GLP, GMP and GA/LP; provides guidance in writing Standard Operating Procedures as needed. Promotes safety training and monitors OSHA compliance. Schedules projects, personnel, and equipment to achieve objectives using internal and external resources. Evaluates and approves all data generated. Directs special troubleshooting investigations of product deviations/complaints, manufacturing deviations/failures, and laboratory suspect data or out-of-specification data. Provides methods, validation reports, and chemical profiles to Regulatory Affairs for FDA or EPA submissions. Prepares and provides responses to FDA, EU or EPA questions on product submissions. Oversees the design and evaluation of special projects related to manufacturing support, raw material testing, or new instrumentation introduced into the QC laboratory; represents QC in Project Teams. Analyzes and interprets data for project reports. Reviews raw data and final results of normal manufacturing samples in support of daily operations. Evaluates new analytical methods for use in the QC laboratory. Directs and/or develops and validates new or improved analytical methods in support of Continuous Improvement activities. Responsible for all laboratory PRO responsibilities including SOPs, TMs, and raw material specifications. Performs and/or assists in assessing PMP\'s of laboratory staff, directing their work to ensure proper test performance and timely release of products. Responsible for developing SOPs for new instrumentation and reviewing raw data and final results for special projects, including proposed changes to manufacturing processes and raw materials. Provides technical consultation to assure efficient transfer of test methods and technology from Pharmaceutical Research and Development to Quality Control and contract laboratories. Manages time estimates to support objectives and prepares operating budgets and capital equipment requests. Controls cost center budgets, approves purchase orders, and initiates AFE\'s for approved capital items. Develops job requirements, reviews performance of Special Project personnel, and selects candidates when filling positions. Keeps current with literature and professional meetings to stay abreast of state-of-the-art laboratory procedures and equipment. If necessary, assists in daily laboratory operations due to staffing shortages or high workload. Oversees and maintains laboratory operations and activities to support Site and Researcher registrations for handling and manufacture of DEA controlled substances. Qualifications Candidates must have: Bachelors of Science with 10 years of industry experience or Masters of Science with 6 years of industry experience or PhD with 4 years of experience. In-depth knowledge of laboratory instrumentation and methods including chromatography (HPLC, GLC, Fluorescence, Laser Light Scattering, TLC), spectroscopy (UV/VIS, AA, FTIR), physical analysis and auto titration equipment. Experience in planning and developing, validating and transferring analytical methods with a proven track record; ability to solve problems using analytical techniques. Broad understanding of all areas of chemistry to suggest innovative solutions; strong knowledge of statistics related to analytical data and computer-based data handling. Ability to motivate and manage technical personnel; capable of coordinating personnel to complete projects on time. Skills in administration, written and verbal communication, budgeting, cost analysis and forecasting capital expenditures. Ability to interact with technical and management personnel at various levels in an international environment to satisfy government requirements and transfer analytical methods. Capacity to motivate people to complete multiple tasks under pressure to meet deadlines; ability to design, conduct, and evaluate project-related work. Team player with good judgment in technical matters related to problem solving in a QC environment; ability to resolve employee personnel issues. Leadership maturity to guide laboratory staff in policies, hiring/firing decisions, and cross-level communication when necessary. Please note the education and work experience to consider in filling this position. #J-18808-Ljbffr