QA Specialist
Medline Industries - santa clarita, CA
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Value Proposition As a leading partner in healthcare, Medline Canada's sole purpose is Together Improving Care - this means being deeply committed to the health and well-being of our customers, employees, partners and our communities. We employ a diverse group of top talent focused on growing and making a difference in the lives of Canadians, coast-to-coast. Compensation is only one part of the Employee Value Proposition that Medline Canada offers our employees. As part of our mission, we offer one of the most competitive and engaging employee experience programs in Canada, which includes: Collaborative work environment with highly engaged employees Market competitive compensation and benefits plan, including LTD & Insurance DPSP match program Annual Employee Appreciation Week Paid vacation and personal days Lifeworks® Employee Assistance Program (EAP) Resources supporting mental, physical, family and financial well-being Career growth and training programs Open communication with Senior Leaders Tailored incentives for eligible employee groups, such as home office reimbursement and Sylvan Learning Centre credit Employee referral program Education support programs Fitness subsidy Recognition programs Social activities And much more... JOB SUMMARY The QA Specialist assists in implementing and maintaining the Quality Systems of Medline Canada. The QA Specialist is primarily responsible for reviewing and releasing drug and NHP products, ensuring compliance with GMP and maintaining procedural training records in the Reliance documentation system for Medline Canada personnel. CORE JOB RESPONSIBILITIES In accordance with Canadian Drug and NHP GMPs, prepare and maintain documentation/files for imported Drug and NHP products. This includes obtaining master production files, stability data, reviewing batch records and determining product compliance with GMP requirements, and coordinating testing and release of imported Drug and NHP products. 40% Obtain review and maintain Quality Agreements with drug/NHP suppliers. This includes all vendors of drug products sold by Medline Canada, both imported and domestic obtained products. 10% Review temperature monitoring of Medline Canada warehouse facilities and pest control reports. Take appropriate actions to follow up on temperature excursions or significant pest issues. Review the cleaning logs to ensure cleaning procedures are followed. 20% Act as Site Administrator for the Reliance Document Training module. With assistance of Sr. Director QARA, ensure all Medline Canada personnel train in a timely manner and training records are up to date. Review and maintain the Reliance Training Group Requirements and adjust accordingly. Assist Medline Canada personnel with Reliance inquiries. 10% Assist with the creation and revision of Canada SOPs to ensure procedures are current and relevant. 10% Maintain foreign site information and review to ensure renewal dates are addressed. Work with vendors to obtain information required for application to Health Canada for the addition and/or renewal of Foreign Sites to Medline Canada's Drug Establishment License (DEL) and Natural Health Product Site License. 10%
Created: 2024-10-09