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Director of Quality Control and Analytical Development
2 months ago
We are seeking a highly skilled and experienced Quality Control and Analytical Development Lead to join our team at Hyper Recruitment Solutions. As a key member of our organization, you will play a crucial role in ensuring the safety and conformity of our production processes.
Key Responsibilities:- Establish and Direct Strategic Vision: Develop and implement robust quality control workflows to meet stringent industry standards.
- Develop and Conduct Analytical Assays: Innovate with new equipment and techniques, and manage a dedicated team of analytical scientists.
- Oversee QC Lab Operations: Liaise with external testing labs, coordinate with satellite QC labs at manufacturing sites, and ensure clear communication of results to stakeholders.
- Implement Quality Management System: Collaborate with the Facilities and Laboratories team to implement a top-tier quality management system, authoring risk assessments, SOPs, and managing essential quality documentation.
- PhD in Relevant Field: A PhD in cell biology, microbiology, biochemistry, or proven industry experience in a GLP/GMP cell culture production environment.
- Quality Management Experience: Extensive experience in quality management, QC/QA, or CMC related to cell culture processes, with high levels of proficiency in writing quality documentation and reports for regulated products.
- Analytical Chemistry Expertise: A thorough grasp of molecular biology and analytical chemistry assays, such as ELISA, biochemical assays, mass spectrometry, and microbiology.
Key Skills: Quality Control, Analytical Development, Food Science, Biotechnology, GLP, GMP, Cell Culture, Quality Assurance, Regulatory Submission, SOPs, HACCP, ISO 9001, ELISA, Mass Spectrometry.
