POSITION OVERVIEW: The Senior Quality System’s Coordinator shall provide direct support and coaching to all levels of management regarding change management, CAPA management and validation projects. The Sr. Quality Systems Coordinator will also support project teams in integrating quality into their projects plan.
JOB RESPONSIBILITIES:
The candidate shall provide direct support and coaching to front-line managers and supervisors as they help their direct reports through transitions.
The candidate shall be responsible for the oversight of the Customer Change Request Process by ensuring that all elements required for change requests, reviews, and implementation as defined per the governance of the Change Management SOP.
The candidate shall be responsible for maintaining the Change Control Dashboard which will be utilized to review, track and monitor the status of Change Requests and Deviations.
The candidate shall be responsible for the coordinating and leading Change Review Board Meetings with all affected stake holders.
The candidate shall be responsible for managing open deviations through review of deviation content, proper approval signature presence and ensuring steps needed for deviation implementation have been completed for deviation closure.
The candidate shall be responsible for the oversight of the New Kit Review Process by verifying BOM content accuracy; initiating the process for sample kit creation; initiating and routing of Sample Kit Approval Form and the preparation of materials needed for customer review and approval.
The candidate shall be responsible for the review of Implementation Plans as defined per the governance of the New Account and Item Implementation SOP to ensure that their content, is accurate, complete and all required approvals have been received and properly documented.
The candidate shall be responsible for ensuring that communication of Upon Depletion Customer Change Requests (Running Changes) has been properly documented and communicated to proper site departments and staff members for awareness and execution.
The associate shall support he record control process as outlined in the SOP that governs record control.
The associate shall support all other administrative duties as required within the Quality Department.
ABILITIES REQUIRED:
Ability to prioritize and shift priorities quickly as need dictates
Basic knowledge of Microsoft Windows & Office
Ability to develop a strong understanding of our products and services to effectively handle Quality related concerns
Proficient verbal and written communication skills
Team-oriented with commitment to the success of the team and organizational goals to track and complete assignments
Ability to multi-task
Other tasks as defined by the site’s needs
QUALIFICATIONS
Bachelor’s degree in business administration, quality management, life sciences or a related field.
Previous kitting or quality experience preferred.
Effective verbal and written communication skills and ability to share and receive information from all levels of the organization throughout various departments
Ability to constructively challenge concerns and engage in transparent conversations
Ability to successfully balance and prioritize multiple ongoing projects/tasks in a fast-paced, deadline driven environment
Ability to identify, analyze and solve problems with minimal direction and escalate concerns to executive management
Drive for results and continual improvement through ensuring procedures and processes are in place for Change Management, that lead to the delivery of quality results and continually assess their effectiveness to drive continual improvement
DISCLAIMER
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
