Compliance Training

4 weeks ago

Bowmanville East, Canada Thermo Fisher Scientific Inc. Full time
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description

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.

Essential Functions: Support the migration of job descriptions into the LMS. Support movement of on the job (OJT) training into the LMS for Processing, Packaging and the Lab, including building OJT requirements, adding OJT into curriculum and recording completion for legacy 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).

REQUIRED QUALIFICATIONS

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.

Equivalency: Equivalent combinations of education, training, and relevant work experience may be considered.

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.

Standards and Expectations: Follow all Environmental Health & Safety Policies and Procedures. Work collaboratively with fellow team members, modelling positive team principles and partnering to meet project and departmental objectives. Carry out all duties within strict compliance to quality SOPs and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Actively engage in and adhere to departmental systems in order to maintain a smooth and efficient workflow (visual management, scheduling systems, etc.). Be client and patient conscious at all times. Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engage in problem solving. Models positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working. Proactively identify areas for improvement in the execution of procedures. Communicate risks to timelines in a proactive manner. Consistently strives to improve skills and knowledge in related field.

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.

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