Job Description

Work Schedule Standard (Mon-Fri)Environmental Conditions OfficeDuration: April 2025 - December 2025 (co-op students only)Summary:Provide administrative support to the Compliance department. Support the preparation for regulatory inspections and client audits. Maintain documents and prepare packages to support regulatory and client requests. Assist with regulatory and licensing activities to ensure site compliance with regulatory and corporate requirements. Support the retention sample destruction process to ensure timely destruction of samples. Essential Functions:Provide administrative support for ongoing Compliance projects.Support Compliance auditors regarding inspection readiness, client communication and scheduling of client/ regulatory audits.Support regulatory, corporate, client, and internal audits.Scribe for regulatory/corporate and any for cause or critical client audits.Create/issue memos for regulatory inspection historySend inspection notifications to siteGenerate USDA, Allergen, Viral Letters and BSE / TSE StatementsMaintain the DPL database and assist with FDA Drug Product Listing.Assist clients in procuring and legalizing GMP CertificatesVerify information entered into SAP for new material number creation.Provide eDMS support to the Compliance team by initiating and progressing document revisions.Oversee the retention sample destruction processMaintain a safe working environment and report potential hazards.REQUIRED QUALIFICATIONSEducation:High school diploma/General Educational Development (GED) Certificate is required.Working towards College Diploma or University Degree in relevant technical field.Enrolled in co-op programExperience:Requires no previous related experience.
Equivalency:Equivalent combinations of education, training, and relevant work experience may be considered.Knowledge, Skills and Abilities:Familiar with GMP, HPFBI, FDA and SOP requirements. Excellent interpersonal, organizational, oral and written communication skills. Familiarity with TrackWise an asset. Demonstrated computer proficiency with Microsoft Office programs. Proficiency with the English Language.

Thermo Fisher Scientific