Manager Records and Systems at Sanofi Pasteur in Swiftwater, PA
This position oversees day-to-day activities for the Swiftwater site Quality document management system and Form Control Program. Key Accountabilities:
Responsible for oversight and management of the GxP Form Control Program, ensuring compliance with data integrity and regulatory requirements Performs systems tasks for all GxP documents within the electronic document management system (EDMS). Electronic Document Management System (EDMS) Functional Administrator- Responsible for system access requests, review of system documentation, training, and document creation/revisions. Manages quality events for the department (Deviations, CAPA, Change Controls, etc) Responsible for performing training in a group setting or individually Responsible for compiling monthly periodic review report Manages Quality Documentation projects as-needed Technical Competencies:
Strong working knowledge of EDMS functionality and troubleshooting Experience with Quality systems including:
Geode+, Phenix, MS Office Meet/exceed project timelines and deliverables Excellent organizational, written, interpersonal, leadership, and teamwork abilities Basic Requirements:
Bachelor's Degree and experience with computer systems Minimum 5 years of experience in a cGMP controlled/pharmaceutical industry, preferably in a regulated Quality environment.
Salary Range:
$80K -- $100K
Minimum Qualification
Quality Management, Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Responsible for oversight and management of the GxP Form Control Program, ensuring compliance with data integrity and regulatory requirements Performs systems tasks for all GxP documents within the electronic document management system (EDMS). Electronic Document Management System (EDMS) Functional Administrator- Responsible for system access requests, review of system documentation, training, and document creation/revisions. Manages quality events for the department (Deviations, CAPA, Change Controls, etc) Responsible for performing training in a group setting or individually Responsible for compiling monthly periodic review report Manages Quality Documentation projects as-needed Technical Competencies:
Strong working knowledge of EDMS functionality and troubleshooting Experience with Quality systems including:
Geode+, Phenix, MS Office Meet/exceed project timelines and deliverables Excellent organizational, written, interpersonal, leadership, and teamwork abilities Basic Requirements:
Bachelor's Degree and experience with computer systems Minimum 5 years of experience in a cGMP controlled/pharmaceutical industry, preferably in a regulated Quality environment.
Salary Range:
$80K -- $100K
Minimum Qualification
Quality Management, Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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