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Quality Control TechnicianSt Louis, MO
The core responsibilities of this position are to perform technical executions of qualification protocols on new or upgraded laboratory instruments and equipment software to ensure compliance with applicable SOP’s and cGMP regulations. This involves preparation of any testing materials, e.g. standards, necessary to execute the testing protocols. This position will work with Data Integrity and Quality Control Lab personnel, at the Curium, Maryland Heights site, to identify shortfalls in test protocol language, or equipment/ software functionality and advise and develop corrective measures to complete assigned qualification protocol execution. The Quality Control Engineer shall provide timely execution and notification of any aberrant occurrence to Management/Supervision that presents potential negative impact to quality records. This position will collaborate with others to coordinate instrumentation use for pre-testing and qualification work, work under limited supervision and with considerable latitude for the use of initiative and independent judgment.
• Provide technical input, review and assessment on the development of laboratory equipment software qualification protocols.
• Perform execution of laboratory equipment software qualification protocols, while providing objective evidence and adhering to good documentation practices.
• Prepare testing materials, standards, etc. necessary to perform protocol executions. Assist in the investigation and associated root cause analysis of any protocol deviations.
• Develop corrective measures for any anomalies or deviations associated with qualification protocols.
• Work in a collaborative manner with Data Integrity and Laboratory team members to achieve objectives.
• Able to work independently and manage workload.
• Manage and prioritize projects in an organized and structured manner.
• Maintain current knowledge of federal and international regulations regarding analytical chemistry and cGMP’s and proactively champion validation and optimization initiatives.
• Assist in maintaining QC records such as equipment/instrument drawings and specifications, protocol and validation records and reports, etc., as required to establish and maintain control of all processes, systems and equipment.
• Ensure that all activities are performed to support all assigned tasks confidently and consistently.
• Perform all work in compliance with site safety and radiation protection guidelines.
• Bachelor Degree in Chemistry or related field required.
• Minimum 3 years of experience in a regulated laboratory setting working with equipment.
• Proficient in the use of several of the following laboratory instruments: Analytical Balance, pH meter, automatic pipettes, FTIR, UV-Vis, Voltammeter, Autotitrator, ICP, Flame AA, TOC, Conductivity meter.
• Working knowledge of GMP regulations, Data Integrity requirements, and Good Documentation practices, as they relate to a QC laboratory.
• Working knowledge of regulatory and compendial guidelines concerning the establishment, documentation of test procedures, and equipment qualification and validation.
• Ability to work independently and with others to accomplish goals and priorities in the nuclear medicine industry.
• Ability to effectively adapt to changing priorities. Results driven.
• Ability to do simple to complex math calculations, input data into the computer and analyze data, as required.
• Ability to multitask projects and work independently on long term tasks with minimal supervision, taking initiative to communicate details and issues to the team and management, as appropriate.
• Excellent attention to detail.
• Must be proficient in use of Microsoft suite office products; demonstrate good computer skills, including utilizing personal computers and data entry programs.
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