Specialist II Change
$52,000–$104,000 year
On-siteSan Ramon, California, United States
Job Summary
Coordinate and control the processing of document and part changes, including delegation within Documentation Control and assignment of urgent changes. Monitor incoming change requests to ensure timely processing, communicate business priorities, and act as the first point of contact for Documentation Specialists. Provide training and coaching to staff, deliver Windchill training, and compile monthly data for supervisor reports. Assist in coordinating change requests across all affected areas and facilities, including remote sites, while supporting Quality Management Systems and FDA regulations. Maintain controlled documentation databases, update departmental procedures, and lead project initiatives as required.
Required Qualifications
- Equivalent High School Diploma / GED
- Minimum 1- 5 years in an FDA or ISO controlled industry
- Yes, 5 % of the Time
Desired Qualifications
- Additional training of Document Control and Configuration Mgmt concepts
- Knowledge of FDA, GMP, and ISO 13485
- Ability to deliver training in a classroom setting or one-on-one
- Be able to direct or guide departmental personnel
- Solid computer skills and report writing skills
- Preferred Knowledge of ERP/PDM databases (i.e. SAP, Mfg-Pro, Windchill)
- Ability to work in a highly matrixed and geographically diverse business environment
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment
- Ability to leverage and/or engage others to accomplish projects
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
- Multitasks, prioritizes and meets deadlines in timely manner
- Strong organizational and follow-up skills, as well as attention to detail
- Ability to maintain regular and predictable attendance
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