QC Supervisor

Full-Time Pharmaceutical in Shawnee Mission, Kansas, United States • Oversees and supervises the full daily laboratory operations, to maintain the highest level of regulatory compliance and customer needs. • Serves as Departmental Manager in the absence of the Manager. • Collaborate with our 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. Supervise preparation of associated scientific documents and reports. Approve test methods, method validation, and transfer reports. • Assist/directs departmental staff through the Daily Operations Team Leader to assure analyses for customers meet requirements to avoid delays. • Direct analysis of raw materials, preliminary formulations, process development and validation samples for new formulations and storage stability samples and provides stability data to the Pharmaceutical Quality Control Stability group. These data are used to obtain FDA, EPA registrations as well as with international registrations and to establish expiration dates for drugs. • Assist Manager in developing and adhering to the departmental annual budget. • Assist Manager in achievement of departmental and divisional goals. • Supervise, train, motivate and develop personnel working in the lab area. Provide opportunities to attend professional meetings to improve technical knowledge. Lead our client's Quality Improvement Process in Pharmaceutical Analysis. • Enforce guidelines necessary to comply with government regulations such as GLP’s, GMP’s, and GALP’s. Provide guidance in the writing of Standard Operating Procedures as needed. Promote and lead safety training and monitor compliance with OSHA regulations. • Schedule projects, personnel, and equipment to achieve objectives using internal and external resources. Evaluate and approve all data generated. • Directs special troubleshooting investigations of product deviations/ complaints, manufacturing deviations/failures, and laboratory suspect data or "out-of-specification" data. • Provide methods, validation reports, and chemical profile to Regulatory Affairs for FDA or EPA submissions. • Prepare and provide responses to FDA, EU or EPA questions on product submissions to Regulatory Affairs for reply to the agencies. • Oversees the design and evaluates special projects relating to such activities as Manufacturing support, raw material testing, or new instrumentation introduced into the QC laboratory. Represent QC in Project Teams. • Analyzes and interprets data for the preparation of reports for assigned projects. • Reviews raw data and final results of normal manufacturing samples in support of daily operations. • Evaluates new analytical methods intended 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 SOP's, TM's, raw material specifications, etc. • Performs and/or assists Manager in assessing PMP's of laboratory staff, directing their work to assure proper test performance and accurate results for release of products on a timely basis. • Responsible for development of SOP's for new instrumentation for the laboratory. • Reviews and evaluates raw data and final results generated in the lab for special projects, including proposed changes to manufacturing processes and proposed raw material changes. • Consult and provide technical assistance as required to assure efficient transfer of test methods and technology from Pharmaceutical Research and Development to Quality Control and contract laboratories. • Provide personnel time estimates to support objectives and prepare operating budget and capital equipment requests. Control cost center budget. Approve purchase orders and initiate AFE’s for approved capital items. • Develop job requirements and review and evaluate the performance of Special Project personnel. Select candidates to hire when filling positions. • Review the literature and attend professional meetings in order to improve and stay abreast in technical knowledge and to obtain and utilize state-of-the art laboratory procedures and equipment as appropriate. • If necessary, assists in daily laboratory operations by performing analyses of all product types, as required, due to staffing shortages or high work load. • Oversees and maintains laboratory operations and activities as needed, to support Site and Researcher's registrations for the handling and manufacture of DEA controlled substances. Required Qualifications: • Bachelors of Science and 10 years of industry experience or Master of Science and 6 years of industry experience or PHD and 4 years of experience. • The incumbent must have an in-depth knowledge and understanding of laboratory instrumentation and methods including chromatography (HPLC, GLC, Fluorescence, Laser Light Scattering, and TLC), spectroscopy (UV/VIS, AA, FTIR) and physical analysis and auto titration equipment. • Candidate must have a good insight into planning and be experienced in the development, validation and transfer of analytical methods with a successful record of past accomplishments. He/she must be familiar with and understand how and when analytical techniques can be used to solve special problems that may arise. The incumbent must have a broad understanding of all areas of chemistry in order to suggest innovative solutions to problems. • The incumbent must have an in-depth knowledge of statistics related to analytical data and knowledge of computer-based data handling. The incumbent must be able to quickly give technical advice and make decisions concerning prioritization of projects. • The ability to motivate and manage technical personnel is required. • Candidate must possess the ability to coordinate personnel to complete projects on time. Skills in administration, written and verbal communication, budgeting, cost analysis and forecasting capital expenditures are also required. • Candidate must have the ability to interact with various levels of technical and management personnel in an international environment in order to complete projects, satisfy government requirements and facilitate transfer of analytical methods. • The incumbent must be capable of motivating people to complete multiple tasks under extreme pressure to meet deadlines • Must have the ability to design, conduct, and evaluate project related work. • Must work well in a team situation and with others, both scientific and nonscientific. Must have demonstrated good judgment in technical matters relating to problem solving our client's. Q.C. environment. • Must possess skills to resolve employee personnel issues. • Should have a leadership maturity level which can support & lead laboratory staff in the areas of Company policies, hiring and firing policies, using appropriate communication among several management levels, when necessary.

Candidates Must Have: Bachelors of Science and 10 years of industry experience or Master of Science and 6 years of industry experience or PHD and 4 years of experience.

The incumbent must have an in-depth knowledge and understanding of laboratory instrumentation and methods including chromatography (HPLC, GLC, Fluorescence, Laser Light Scattering, and TLC), spectroscopy (UV/VIS, AA, FTIR) and physical analysis and auto titration equipment.

Please notice the education and work experience to consider in filling this position.

Openings: 1 Start date: 10/12/12

Please send cover letter and resume in word doc format ASAP  to ~ admin@tfastaffing.com

(P) 866-932-2687