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Change Management with GMP Pharmaceutical

Company: Alpha Consulting
Location: Elkton
Posted on: January 26, 2023

Job Description:

*CHANGE MANAGEMENT WITH GMP PHARMACEUTICAL **ELKTON, VA**Required Skills: ** A bachelor's degree in science, engineering, or equivalent discipline with one to two years' experience in a cGMP environment (technical, and/or quality).* Chemistry knowledge to differentiate between chemical substance properties, storage conditions, and differences in quality grades.* Raw material and/or single use component qualification knowledge.* Knowledge of compendial differences in requirements for raw materials and single use components.* GMP compliant documentation practices and data integrity.* Experience with SAP software (navigation and data review/extraction).* Ability to clearly communicate requirements and expectations with stakeholders with varied technical and non-technical backgrounds (business, quality, engineering, manufacturing, supply chain, production systems and compliance frameworks).* Understanding of supply chain assessments and evaluation processes.* Supplier relationship/point of contact experience.* Change management with a CGMP environment.* Materials knowledge in support of the position responsibilities (compatibility, extractables, general chemistry).* Strong verbal and written communication skills, team skills, personal character, and ethics.* Strong problem-solving skills and hands-on approach to problem solving.* Enthusiasm, confidence, and initiative taking ability needed for continuous learning and its applications.* Strong desire to succeed and help others do the same.* Experience with component and material builds, within an SAP environment is preferred but not required.* Supplier relationship experience is preferred.*Project Description: ** End to end raw material and single use component support including - material selection, qualification, material build into Client systems, supplier compliance support, and continuous improvement.* Creation, qualification, and commercial use implementation of new raw material and single use technology supply chains.* Extension of raw material supply chains and single use technology materials from other commercial and development products.* Qualification of single use technology for compatibility biocompatibility extractables and other processes sustainability characteristics.* Interaction with suppliers and using areas to manage design and sustainability of single use technology.* Management of change elements supporting new and extended raw material supply chains and single use devices.* Ongoing interaction with local and extended network manufacturing, development organizations, communities of practice, and centers of excellence for the selection and deployment of single use technology.* Design and execution of continuous improvement projects in support of these responsibilities, including procedure inform management.This 6+ month position starts ASAP.ALPHA'S REQUIREMENT #23-00154MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEEJob Types: Full-time, ContractBenefits:* 401(k)* Dental insurance* Health insurance* Health savings account* Referral program* Vision insuranceSchedule:* Monday to FridayWork Location: One location

Keywords: Alpha Consulting, Richmond , Change Management with GMP Pharmaceutical, Executive , Elkton, Virginia

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