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Responsible for managing controlled documents such as SOPs, Work Instructions, Forms, Policies, and Knowledge Assessments. Duties include circulating documents for review and approval, uploading them into the Document and Training System, and ensuring compliance with templates and procedures.
Responsibilities :
Maintain all controlled documents and assist company personnel with the creation and revision of all controlled documentation ( SOPs, WIs, Forms, KAs, etc.).
Monitor shared mailbox and respond to company personnel for documents that require to be created, revised and / or inactivated.
Ensure adherence to established templates and procedures.
Verify document change requests, perform review of documents for accuracy and consistency before circulating for approval.
Assist document authors with navigation in electronic document management system, formatting, and workflows of documents.
Store, manage, and track documents throughout entire lifecycle.
Scan, image, organize, and maintain documents.
Archive inactive records in accordance with the records retention schedule.
Assist with audit preparation and audit support as required.
Maintain curricula, learning plans, and training records, record training and learning events via the internal Training Management System.
Update internal Training Management System as needed to support internal Fisher training requirements.
Run reports in the Training Management System and provide training data to functional areas for trending purposes as requested.
Troubleshoot issues found in the Training Management System and enter courses / tests e-learning content.
Support other business needs as required.
Regularly attend meetings regarding training and document systems
Qualifications :
A minimum of years’ experience in the pharmaceutical or related regulated industry.
Familiar with Quality Systems (change control, deviations, documentation management, and training system).
Ability to understand and implement priorities and workload and to establish strong collaborative relationships with peers.
Good communication, diplomacy skills and be able to work effectively with internal stakeholders.
Must be detailed oriented to detect errors or deficiencies when reviewing and releasing documents for approval.
Ability to work effectively within various electronic document templates and provide assistance and guidance to authors when requested in relation to these documents.
Experience with electronic Document Management Systems.
Experience with electronic Training Management Systems
Physical Requirements :
Ability to stand, bend, reach, walk, and lift up to pounds
About US Tech Solutions :
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To learn more about US Tech Solutions, please visit .
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.