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Senior Quality Specialist I - Method Validation and Development Chemist

Company: System One
Location: Wilson
Posted on: September 19, 2022

Job Description:

Title: Method Validation & Development Chemist Location: Wilson, NC Schedule: Monday - Friday Type: Direct Hire Start date: ASAPResponsibilities: Perform a variety of chemical analyses and GMP review of raw materials, packaging components, ancillary solutions, in-process samples, finished product samples, and stability samples in accordance with cGMP, GLP, DEA, and company policies and procedures. Author and review protocols for method development, method validation, method transfer, and/or process validation. Execute protocol testing, data review, report writing, and report reviewing. Conduct equipment validations IQs, OQs, PQs, and MQs, if necessary. Provide assistance and technical support to other groups with chemical testing needs and performs troubleshooting of analytical methods and instrumentation. May be responsible for technical supervision of Quality colleagues and serve as back-up to management to ensure smooth and efficient operation of the lab. Serve as an analytical project lead for all assigned products. Project leads ensure all required testing is completed to support the overall project timeline. Perform all assigned testing in a timely and organized manner in accordance with cGMP, GLP, DEA and company policies and procedures. Accurately document all necessary and relevant information in a clear concise manner as per cGMPs. Operate and maintain all analytical instrumentation and equipment as per established procedures. Write, revise, develop and evaluate operational and maintenance procedures. Communicate openly within the group to provide and gather information, to optimize the use of resources, and to optimize efficiency. Provide training and assistance to other group members.Requirements: Must have a BA or BS Degree in Chemistry or closely related science with six years minimum laboratory experience in pharmaceutical or related industries; or a graduate degree (MS Preferred) with 4-7 years' experience. Relevant experience may include academic and/or industry experience and is measured based on the quality and quantity of the experience as it relates to the requirements of the position. Must demonstrate sound comprehension of multiple analytical technologies (HPLC, GC, Dissolution, Automation, or Spectroscopy - UV/Vis, Raman or IR); and must have a comprehensive knowledge of cGMPs and FDA requirements as well as familiarity with USP and EP monographs.Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services.For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.

Keywords: System One, Wilson , Senior Quality Specialist I - Method Validation and Development Chemist, Other , Wilson, North Carolina

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