Configuration Management Specialist, Blood Products

Position Summary

The Configuration Management Specialist is responsible for performing tasks that drive the timely release and change of product documentation and supporting data throughout the product’s lifecycle. This position will evaluate and process electronic change orders for completeness and adherence to procedure and will ensure appropriate distribution and notification. This position will ensure accurate record retention of Quality System documents in accordance with defined requirements and procedures. 

Principal Responsibilities

•    Subject matter expert in change control as it relates to product lifecycle.
•    Facilitate the timely change, approval and release of product documentation and data (PLM, ERP).
•    Ensure all documents follow appropriate naming and numbering procedures.
•    Performs document issuance for testing and manufacturing and assures appropriate reconciliation of documentation.
•    Support development of new product documentation and provide detailed reports, queries or summaries in support of various cross-functional projects and initiatives.
•    Provide audit and inspection support, as requested.
•    Provide inventory control and maintenance of the central document reference library, including standards and guidelines.
•    Prepare Quality records for electronic scanning and off-site archiving.
•    Administer the system for archiving and off-site storage of document control and data records in accordance with defined requirements.
•    Maintain new Item Master set-up and other related data in applicable ERP, as applicable.
•    Provide high level customer service and support to specific cross-functional areas.
•    Assist in monitoring process effectiveness including the impact of changes and take the initiative to recommend process improvements and assure procedures are in place to classify and maintain appropriate records.
•    Apply best practices of change control and configuration management.
•    Participate in and/or lead special projects, as assigned.
 

Education / Experience Requirements

•    Bachelor’s Degree preferred
•    The successful candidate will have a minimum of two years relevant experience and a high level knowledge of quality systems, compliance and change control requirements in a regulated industry.
•    Broad functional expertise in change control management
 

Specialized Skills / Other Requirements

•    Excellent written and oral communication skills
•    Working knowledge of quality systems and compliance in a regulated industry
•    Experience with PLM and ERP software
•    Subject matter expert (SME) in change control and record retention processes
•    Detail oriented and self-directed with good time management skills 
•    Ability to work collaboratively and independently
•    Ability to effectively execute projects and related activities with appropriate priority required
•    Excellent critical thinking skills & ability to identify and solve problems of moderate scope & complexity
•    Ability to function as part of a team and achieve results through open collaboration with others 
•    Results oriented with the ability to be accountable to the achievement of both individual and team goals
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