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.
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