QC Manager
On-siteJayuya, Jayuya, Puerto Rico
Job Summary
Direct and manage all Microbiology and Chemistry Laboratory operations, coordinating activities with Manufacturing and Supply Chain teams while leading, supervising, and training laboratory personnel. Establish, implement, and maintain standard operating procedures, policies, and testing programs for raw materials, in-process materials, finished products, and stability programs. Ensure compliance with FDA regulations, USP standards, and cGMPs by conducting investigations, performing trend analysis, and overseeing validation activities for equipment, processes, and methods. Develop and manage departmental budgets, maintain laboratory technologies and equipment, and evaluate service supplier contracts. Lead method transfer activities and support continuous improvement initiatives through laboratory automation.
Required Qualifications
- Bachelor's degree in Chemistry, Microbiology, or a related scientific discipline
- Minimum of 8 years of experience in Quality Systems within a regulated environment
- Minimum of 3 years of management or supervisory experience in a laboratory setting
- Experience with wet chemistry and/or microbiology laboratory procedures
- Root Cause Analysis training and practical experience
- Working knowledge of applied statistics and statistical tools
- Strong understanding of FDA regulations, USP standards, cGMPs, laboratory operations, and quality systems
- Experience with laboratory validation programs, method transfers, and stability programs
- Proven ability to train, motivate, coach, and develop employees
- Strong presentation and communication skills
- Demonstrated success in change management and leading organizational change
- Demonstrated commitment to integrity, accountability, teamwork, collaboration, and performance excellence
- Strong facilitation and conflict resolution skills
- Fully bilingual in English and Spanish
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