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Subject: Change Control Manager-Phila Suburb.

Robert Ciociola posted a job: Change Control Manager-Phila Suburb.

"Contract psoition-12 months Send resumes to: bciociola@covexllc.com Job Description Fluency in Spanish desirable. • Executes projects and tasks associated with the US OTC Change Control process and associated system. • Prepares agendas, schedules Change Control ad hoc and Committee meetings, compiles and disseminates minutes and performs other administrative tasks. • Performs tracking and trending activities associated with monitoring process performance. • Identifies and notifies management of issues and incidents associated with the Change Control process or individual Change Controls. • Processes documents in the electronic system. • Participates in team(s) related to the Change Control processes and systems • Responsible for ensuring the quality and compliance aspects of the Change Control process are adhered to and enforced. A minimum of a Bachelor's degree is required. BS/BA Degree in an engineering, chemistry or life science program. Experience Minimum 5 years GMP experience in the drug, device or biologics manufacturing environment. Minimum 3 years experience in a Quality function or role. Experience operating or supervising a Change Control process preferred. Experience preparing, processing, reviewing and approving change control documents highly desirable. Knowledge/Skillsets Candidate must demonstrate excellence in influencing skills, communication skills & strong people management. Candidate must possess strong organizational skills, be process oriented, evaluate issues from a strategic perspective & integrate strong analytical skills. In addition, the candidate must be a Change Agent by delivering timely decisions with minimal information. Process Excellence competency is a plus. Candidate must be able to manage complex issues, identify quality and compliance related issues, and proactively address, escalate and communicate clearly and concisely to all levels of management. Excellent oral and written communication skills. Efficiency with MS Office"

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