• Full Time
  • Windsor

Trevor Frances Recruitment

We are seeking a proactive Quality Assurance Coordinator to join our team. In this role, you will support all Quality Systems to ensure quality manufacturing of products as defined by current Good Manufacturing Practices (GMP). You will assist other departments with quality and GMP issues, ensuring compliance with all relevant regulatory requirements. You will also be accountable for the timely release of bulk softgel capsule products to cGMP standards. Responsibilities: Act as a qualified person in the release of finished products, as defined by relevant GMP guidelines. Follow and maintain GMPs and GLPs for the facility. Utilize ERP, LIMS, and QMS systems for daily functions. Work in a team environment to ensure all Quality job functions are covered. Support QC Samplers/Technicians and R&D on-site with LIMS tasks. Assist other departments with quality-related issues. Audit batch records and approve the release of materials and products in the ERP system. Review and disposition material and product Certificates of Analysis (CofAs) in the LIMS system. Handle and coordinate Out of Specification investigations in LIMS. Manage the Material retest/expiry program and rejection process. Prepare, revise, or approve master formulas, batch records, and material/product specifications. Lead specification update projects, including supplier alignment. Coordinate Environmental monitoring and trending results. Review and trend Purified Water System testing results. Perform production batch adjustments and review lot continuations. Prepare rework/reclaim masters and conduct formal AQLs and carton AQLs. Conduct internal audits, complete reports, and track corrective actions. Perform rotational facility inspections and assist with external audits. Prepare and review documentation for facility customer, third-party certification, and government audits. Maintain accurate QMS systems/databases, including deviation investigations, complaints, change control, and CAPA. Investigate, trend, and complete reports for deviations, complaints, and OOS. Create and implement CAPA plans and conduct CAPA Effectiveness checks. Initiate continuous improvement training notices and operational communications. Review and approve change control deliverables. Back up Quality Associate duties, including SOP system, training files, document filing & archives, quality metrics, and temperature/humidity monitoring. Conduct new hire GMP orientation training and write or revise SOPs and controlled forms. Review production logs, QC logs, and facility records. Prepare or review RMQ and VQ packages. Prepare Annual Product Reviews (APR) and Trend reports. Review validation protocols, data, and reports. Prepare technical documents and study protocols. Order lab supplies. Work in compliance with Health & Safety Policies/SOPs. Qualifications: Minimum Bachelor’s Degree in a science-related field. Minimum 2 years of practical Quality department experience in a pharmaceutical, nutritional, food, or health products manufacturing environment. Comprehensive knowledge of manufacturing operations and cGMP. Experience in softgel manufacturing is an asset. Knowledge of pharmaceutical, food, and natural health product regulations. Excellent communication and problem-solving skills. Proficient with computers and quality systems software. Team-oriented with a high work ethic. Self-starter and critical thinker. Ability to work with minimal supervision, including shift work and overtime as required. We prioritize personal ownership and accountability in our work. We value respect, actively listening to and engaging with diverse perspectives. We strive for excellence, constantly challenging the status quo and pursuing innovative ideas. Agility is key, as we embrace change and swiftly incorporate feedback to improve our performance. Join our team and contribute to the efficient and compliant production of high-quality products! About Trevor Frances: Trevor Frances is a specialized talent solutions firm dedicated to connecting skilled professionals with opportunities across various industries. We offer permanent positions with leading companies.

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