Change Management Specialist
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**MEMBERS ONLY**SIGN UP NOW***. is seeking an experience Change Management Specialist to work at one of our customers in Westport. For this role the idea candidate will have GMP experience along with manufacturing exposure and great attention to detail. Provides assistance with change management quality oversight for the GMP systems for the manufacture of commercial medical devices. Ensures that GMP changes are executed efficiently and effectively through managing the creation, evaluation, execution, and closure of GMP changes based on quality requirements, global standards, and processes. The Change Management specialist partners with change owners to ensure there is a robust dialog and complete vetting process for changes at the site. The scope of this role includes oversight of all changes considered to have GMP and/or validation impact, which will include a variety of functional areas within the site. Role Responsibilities: Facilitate the site Change Control Review Committee meetings: Maintain a routine schedule of meetings Ensure appropriate quorum is represented Ensure specific individuals are invited as needed Call for agenda items Publish agenda Publish minutes and attendees Maintain a GMP record or repository of agendas and minutes. Assist with Quality System Oversight: Routinely query the change management system for schedule adherence/ performance Assist with the creation of clear and concise parent change records to support GMP changes Assist with the creation of change management action items (child records) needed to support a GMP change Decisions/Approvals: Review content and approve interim reports for parent records and associated action items (first IR) Designated representative for the Change Control Review Board, provide change management pre-approvals on behalf of the committee based on committee decision Review and approve child records Metrics: Prepare metrics to site leadership team Training: Provides system training to user groups Maintains training materials Qualifications: Degree preferred: 4 Year degree (BS or BA) in Chemistry, Biology or other related science or engineering field. Experience 3-5 years with Change Control and GMP compliance Proficient in Microsoft Excel, Microsoft Word & Adobe Acrobat Ability to work independently with minimum supervision Highly organized with great attention to detail Must be able to prioritize tasks and resolve routine issues Must have experience working in a fast paced environment Excellent verbal and written communication skills Excellent organizational skill