Share Position: Change Process Specialist Job Code: 5551
Location: GOJO Plaza, Akron, Ohio
- Full time
- Work Hours 8:30 a.m. to 5:00 p.m.
- No direct reports
- < 10% travel required
- No relocation assistance
Provides support required by the Change Management process for Change Process Manager and other teams (e.g., Product Portfolio Management, Product Systems) to meet cGMP requirements. Suggests and participates in continuous improvement process to gain continuous effectiveness and efficiency of processes, controls, rituals and tools for the Change Management process. Acts as back-up for Change Process Manager.
Education and Experience Required
- Support the Change Management process strategies and objectives by creating, implementing, monitoring, and revising Change Management process procedures and systems.
- Creates and maintains Change Management process databases, including artwork and Engineering Change Requests (ECR) files.
- Compiles and prepares reports and analyses using a variety of software in support of the Product Change Management process.
- Monitors the integrity and quality of the Change Management process and implements corrective action when required.
- Applies project organization and implementation skills to assigned projects to ensure timely and orderly completion in accordance with stated objectives.
- Acts as the primary back-up to the Change Process Manager.
- Provides filter of ECRs into the Change Management process to ensure duplications and unnecessary activities do not occur.
- Assists Change Process Manager with orientation and training of individuals involved in the Change Management process to ensure FDA and cGMP compliance.
- Acts as a first contact to research and resolve ECR issues.
- Assists in providing information regarding ECR and Engineering Change Order (ECO) status to the Enterprise on a consistent basis.
- Initiation of EPI update forms to ensure the database contains the most current, correct information.
- Accuracy of Change Management databases, documents and records.
- Assure FDA and cGMP compliance within the Change Management process.
- Engineering Change Request facilitation.
- Effective and efficient initiative management
- Appropriate communications throughout the Enterprise regarding ECR, ECO and artwork issues.
- Coaching ECR initiators
- Reduction of cycle time for the Change Management process.
BS/BA in Business, Engineering or a related field, with a minimum of 3 to 5 years of business experience; experience in document control or configuration management a plus.
Additional General/Technical Skills Required
- Timely project completion
- Data base accuracy
- Disciplined approach to change management that assures FDA and cGMP compliance.
- Effective communications with internal and external customers.
- Doing what it takes to assure that critical project timelines are met.
- Suggests and participates in continuous improvement of the Change Management process.
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- Improved project success through the reduction of project risk and rework.
- Effective and efficient development of new products and changes to existing products, done right the first time.
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GOJO is an Affirmative Action/Equal Employment Employer M/F/D/V. Applicants must be lawfully authorized to work in the United States. GOJO does not seek or respond to unsolicited resumes sent electronically for positions that are not listed below.
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