Document Control & Training Associate

at  Thermo Fisher Scientific

SUMMARY:

Manage GMP document workflows through the respective document lifecycles at site. Perform as Site Administrator of the Electronic Document Management System (eDMS) and the Learning Management System (LMS) to ensure compliance to all applicable standards. Support the archive, retention, and destruction of GMP documents. Support completion of the Corporate Quality Standards alignment process at the site. Support client and regulatory audits as required.

EDUCATION:

High school diploma/General Educational Development (GED) Certificate is required
Working towards College Diploma in relevant technical field
Working towards Bachelor of Science (B.Sc.) an asset.

EXPERIENCE:

Requires no previous related experience.
Previous experience delivering training an asset.

KNOWLEDGE, SKILLS, AND ABILITIES:

Demonstrated computer proficiency with Microsoft Office programs. Strong ideas, decision making abilities, trouble shooting and thinking-out-of-the-box skills. Excellent organizational, verbal and written communication skills. Familiarity with GMPs. Works well with limited supervision. Excellent organizational, interpersonal, oral and written communication skills. Experience in Microsoft Word, Excel, Access. Experience with EDMS, SuccessFactors is an asset. Proficiency with the English Language.

PHYSICAL REQUIREMENTS:

Light physical effort and fatigue. Walks, sits or stands for limited periods. May require occasional equipment operation including keyboard equipment. Lifts light items for limited duration. Typically located in a comfortable indoor area. There may be exposure to mild physical discomfort from factors such as dust, fumes or odours, temperature extremes, loud noise, strong drafts, or bright lights. Use of Personal Protective equipment may be required and may include any of the following: safety glasses, safety shoes, lab coat, gloves, hair net, beard cover, safety apron, respirator on occasionally.

DISCLAIMER:

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as a comprehensive statement of work, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully align with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

• Perform as Site Administrator and subject matter expert for eDMS and LMS.
• Manage aspects of the document lifecycle workflows through eDMS: preparation, review, assignment of training, as well as document inactivation with associated training curricula removal as required.
• Facilitate document lifecycle workflows through LMS: course creation and assignment of training, curriculum maintenance, training verification, curricula maintenance, and curricula removal as required.
• Maintain eDMS and LMS in compliance with all applicable regulations, corporate requirements, and site procedures.
• Collaborate cross functionally to support various documentation and training needs to ensure compliance to requirements.
• Generate system reports to track, trend and monitor training compliance; prepare and distribute site training metrics for eDMS and LMS.
• Support delivery of training as required in support of eDMS and LMS function.
• Author eDMS and LMS system and process related SOPs and WIs as required.
• Complete the periodic (triennial) review process of GMP SOPs and WIs; and LMS training curricula.
• Drive continuous improvement of Document Control and Training through Practical Process Improvement (PPI) concepts.
• Assist with regulatory / client audits as required.
• Manage the process to ensure site document alignment to Corporate Quality Standards and Guidelines.
• Support onsite and off-site archival, retrieval, and destruction of GMP Documents as per retention schedule.
• Maintains a safe working environment and reports potential hazards.
• Performs alternating or rotating shift work (as required)