Quality Control Coordinator

Description

Position Summary: A professional responsible for supervising physicochemical and microbiological analyses, ensuring regulatory compliance and quality in the laboratory, managing resources, and training personnel. Key Highlights: 1. Supervision of physicochemical and microbiological analyses 2. Laboratory quality management and regulatory compliance 3. Laboratory staff training and development **Description** KNOWLEDGE: \- Laboratory and dimensional analysis. \- Preparation of solutions and culture media. \- Handling of chemical reagents. \- Handling of Biological Infectious Hazardous Waste. \- Operation of laboratory instrumentation and equipment. \- Statistics. \- Good Documentation Practices. \- Good Laboratory Practices. \- Good Manufacturing Practices. \- Use of software applicable to the area. \- Handling and interpretation of applicable bibliographic references. \- Physicochemical methods (HPLC, UV, titrations, etc.) \- Applied microbiology \- Method validation \- Regulations: 21 CFR Part 820 ISO 13485 COFEPRIS v Supervise the execution of physicochemical and microbiological analyses according to validated methods. v Supervise: Environmental monitoring Water system monitoring Sterility testing (when applicable) Bioburden Bacterial endotoxins * Ensure compliance with controlled areas and cleanroom classification. * Ensure integrity, reliability, and traceability of analytical results. * Manage laboratory workload, resources, and priorities. * Guarantee appropriate operating conditions (environment, cleanliness, microbiological control). * Ensure compliance with: 21 CFR Part 820 (FDA) COFEPRIS ISO 13485 (Quality management systems for medical devices) * Ensure all analytical methods comply with applicable compendia: Mexican Pharmacopeia United States Pharmacopeia European Pharmacopoeia * Maintain the laboratory in a state of permanent audit readiness. * Approve protocols and reports for: Method validation Analytical transfers Stability studies (when applicable) * Supervise proper use of controls, standards, and reagents. * Train and qualify laboratory personnel. * Evaluate performance and technical competencies. * Identify trends and propose improvements. * Participate in risk analysis (ISO 14971 when applicable). * Manage OOS (Out of Specification), OOT, and deviation investigations. * Participate in batch release jointly with Quality Assurance. * Quality control testing of culture media. "Laboratorios Jaloma, S.A. de C.V." is a company with over 80 years of experience in the pharmaceutical market, committed to quality and innovation in its products. Our work environment fosters professional growth and teamwork, offering opportunities for continuous development and learning to our employees Salary: $23,000\.00 per month Benefits: * Transportation allowance or service * Option for indefinite-term contract * Medical expense insurance * Life insurance * Grocery vouchers Workplace: On-site employment