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Change Management with GMP Pharmaceutical

Elkton, VA

Posted: 01/18/2023 Job Number: 22890971

Job Description

CHANGE MANAGEMENT WITH GMP PHARMACEUTICAL
ELKTON, VA
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.

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.

This 6+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: bridget@alphaconsulting.Com

ALPHA'S REQUIREMENT #23-00154
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

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Bridget Burns

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