Change Control Specialist

3 weeks ago

Titusville, United States Insight Global Full time

Required Skills and Experience:

Bachelor's degree in physical or Life Science; Supply Chain and/or Chemical Engineering

1-3 years of related experience, including significant experience in pharmaceutical or other related highly regulated industry

Knowledge of Quality Systems' processes inclusive of cGMP and FDA regulations.

Proven ability to perform independent work requiring attention to detail, accuracy, and scientific judgment.

Possess excellent interpersonal, written, and oral communication skills with the ability to utilize active listening skills to understand concerns and be responsive in building relationships.

Microsoft (MS) Word, Excel and PowerPoint

Strong Project Management Skills


Nice to Have Skills and Experience:

Experience with Process Compliance/TrackWise heavily preferred.


Job Description:

One of our large pharmaceutical clients is looking to hire for the External Supply Services team that manages the pharmaceutical external manufacturing network, collaborating closely with Partnerships & External Supply, External Quality, Technical Operations, Planning, and Procurement to ensure reliable product delivery and customer service. The team is the supply chain node that supports internal processes for External Suppliers and ensures compliance for Change Control, Serialization and Training.


Essential Job Duties and Responsibilities

The Change Control Facilitator acts as the direct responsible individual (DRI) to actively develop and manage relationships with process users, business owners, J&J affiliates, and external organizations to ensure harmonized and consistent change control processes, and to provide guidance/direction regarding execution. This role will support the development, effective implementation, and continued maintenance of Change Controls to ensure compliance is achieved and standards are met.


-Execution of External Supply change control processes in conformance to current standards and procedures, using applicable system application tools.

-Ensure integrity, consistency, and compliance of processes for all J&J Innovative Medicine.

-Assure successful implementation of changes and actions by following up and synchronizing activities for all participants, communicating status for implementations to key stakeholders.

-Provide product and Supply Chain knowledge to ensure proper implementation and compliance.

-Partner with other areas of the Supply Chain and actively develop and manage relationships with process users, business owners, affiliates, and External Organizations.

-Maintain compliance with all company policies and procedures.

-Ensure audit readiness of global change control process.

-Perform related duties as assigned by supervisor.

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