QC Supervisor

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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…