Change Control Specialist
3 days ago
Change Control Specialist
- Location: Portage, MI (Hybrid)
- Type: W2 contract (NO C2C OR THIRD PARTY)
- Length: until 3/2025 (Contract extension expectation)
- Pay Rate – $25 - $29 hourly
- Work Authorization - Must be able to work in the U.S. with approved authorization status.
A strong candidate will have:
- PLM Experience
- Change Control experience
- GMP experience
What You'll Do:
- Manage and execute complex Engineering Change Notices (ECNs) in our PLM System for Surgical Technologies to support various business and engineering activities.
- Create complex changes within the PLM System to ensure data, documents, content and information submitted in the change is accurate and compliant.
- Collaborates with the necessary stakeholders as needed to build, complete and monitor the Implementation Plan as well as the ECN.
- Facilitate and organize the Change Implementation Board (CIB) when required.
- Act as a subject matter expert in the Change Management/Change Control process as well as the onePLM system.
- Responsible for following the Change Management/Change Control process and procedures effectively within our Quality System.
- Collaborate with stakeholders across several business functions providing excellent customer service while creating and routing complex changes in our Quality System.
- Collaborate with relevant functional groups to mentor and coach teams and stakeholders through the change control process and the workflow within onePLM.
- Under minimal supervision, works with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing, and Project Management to ensure project success.
- May act as the Change Owner as well as the Change Analyst II on changes.
Work Authorization:
- Must be able to work in the United States with current employment authorization documents.
Important information:
- To be immediately considered, please send an updated version of your resume to Danh704@kellyservices.com
- *** (Kelly does not expense relocation/interview costs) **
In addition to working with the world’s most recognized and trusted name in staffing, Kelly employees can expect:
- Paid holidays
- Year-end bonus program
- Recognition and incentive programs
- Access to continuing education via the Kelly Learning Center
- Competitive Pay
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