Quality Assurance Laboratory Manager
hace 2 meses
We are seeking a highly skilled and experienced Quality Control Laboratory Manager to join our team at CooperSurgical. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality in our laboratory operations.
Key Responsibilities- Quality Control Team Management: Lead and manage the Quality Control team responsible for incoming inspection of raw materials and QC testing of finished goods.
- Qualification and Validation: Oversee the qualification and validation activities for the quality control department, including coordination, review, and approval of protocols and reports.
- Equipment Maintenance: Ensure equipment is installed and maintained in a functional state through internal and external preventive maintenance programs and proper training of employees.
- Training and SOPs: Ensure team members are trained and SOPs are updated to accurately reflect processes in the department.
- Continuous Improvement: Drive continuous improvement activities, participate in and/or lead CAPA, NCMR processes, and DMAIC problem-solving activities.
- Performance Metrics: Develop metrics to monitor equipment and process performance, such as Release on time, control charts, capability indices, etc.
- QC Test Specifications: Setup of QC test specifications in QMS and ERP systems together with R&D and Engineering.
- Stability Studies: Coordinate execution of stability studies in collaboration with R&D.
- Compliance: Ensure compliance to industry standards and safety regulations for handling and disposing of test samples and reagents.
- Experience: 3-5 years of experience from lab manager, team leader, or supervisory role in an analytical or microbiological laboratory.
- Education: Bachelor's degree in chemistry, chemical engineering, material engineering, biomedical engineering, microbiology, or similar. Master's degree in the same fields is desirable.
- Skills: In-depth understanding of analytical equipment and methods, equipment qualification, and analytical method validation. Experience with pH, osmolality, ELISA, Viscosity, Density, RP-HPLC, endotoxin testing, and sterility testing is an advantage.
- Language: Fluent in Spanish. Strong written and oral communication skills in English.
- Software: Skilled with MS Word, Excel, Power Point. Experience with Six Sigma Green Belt and solid understanding of Lean Principles, CAPA, and DMAIC problem-solving process is desired.
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