Shift Supervisor overseeing production crews, safety, quality, and KPIs at ROCKWOOL, a stone wool solutions manufacturer. Managing rotating 12 - hour shifts and continuous improvement initiatives.
About the role
- Fractionation Manufacturing Supervisor overseeing plasma-derived medicine production at Grifols Canada. Leading cGMP shifts, personnel, documentation, equipment, and cross-functional manufacturing activities.
Responsibilities
- Lead and direct daily manufacturing shift activities in the Fractionation production area, assigning tasks and following up on progress
- Ensure quality, safety, delivery, and productivity objectives are met
- Issue and investigate quality and preventive-maintenance notifications in a timely manner
- Ensure manufacturing schedules, products, and materials are delivered
- Train Fractionation manufacturing personnel on processes, safety, and cGMP activities
- Identify development gaps and implement applicable plans and targets
- Review safety cases and identify or implement corrective actions
- Develop, train, and monitor personnel to ensure compliant product manufacturing
- Ensure compliance with site procedures, health and safety protocols, and applicable federal health-authority regulations
- Coordinate and prepare reviews of batch-related documents, including batch records and SOPs
- Execute quality management system assignments, including CAPA and change control, and ensure timely closure
- Ensure equipment operates properly and request equipment or facility repairs and modifications as needed
- Resolve operational and equipment issues and coordinate emergency repairs, modifications, and preventive maintenance
- Coordinate manufacturing activities with Quality Control, Materials Management, Quality Assurance, Validation, and other departments
Requirements
- CEGEP diploma or technical degree required
- BS degree in Science, Engineering, or a related field preferred
- Previous experience in biologics protein fractionation manufacturing is an asset
- 1–3 years of manufacturing leadership/supervisory experience in a cGMP biopharmaceutical environment
- Good understanding of process equipment operating principles
- Strong knowledge of technical and scientific principles associated with aseptic processing
- Familiarity with automated control systems
- Knowledge of cGMP, OSHA, EPA, and FDA facility requirements and regulations
- Knowledge of aseptic operations, statistics, equipment design, process control, process scale-up, aseptic pharmaceutical processes, and equipment validation
- Ability to troubleshoot and maintain manufacturing systems, equipment, and processes
- Ability to gown aseptically for cleanroom operations
- Ability to respond quickly to assess and resolve problems
- Excellent communication, documentation, organizational, and troubleshooting skills
- Ability to accurately read, understand, and follow company SOPs and guidelines
- Strong writing and computer skills
- Proficiency in Microsoft Word, Excel, PowerPoint, and Project
- Bilingual in spoken and written French and English; English required for documentation and communication with other Grifols sites
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