Description
Job Summary:
Develop standard operating procedures, ensure continuous improvement, and guarantee regulatory requirements through audits and training.
Key Highlights:
1. Focus on continuous improvement and regulatory compliance assurance
2. Active involvement in physicochemical and microbiological analyses
3. Collaboration with management in the development of technical documentation
**Mission:** Develop standard operating procedures for various departments to ensure continuous process improvement through internal and external audits, handling of non-conformities, identification of process improvement opportunities, and delivery of training to employees. Ensure compliance with the company's regulatory requirements.
**Experience:** Minimum of 2 years of experience preferred in university or industrial laboratories.
**Education:**
**Minimum:** Completed undergraduate degree in Chemistry, Biology, Pharmacy, Biomedicine, Physics, Chemical Engineering, Food Engineering, or related fields.
**Knowledge:** Good Manufacturing Practices (GMP), physicochemical and microbiological analyses, intermediate-level Office suite proficiency, technical document preparation (protocols, reports, procedures), sample management, stability studies, environmental monitoring, basic English. Preferred: scientific writing, 5S, Lean Six Sigma (Yellow Belt).
**Responsibilities:**
* Actively drive the process, ensuring timely delivery by performing ME, MP, and PA physicochemical analyses; liquid and gas chromatography; microbiological analyses; and environmental monitoring for release or investigative purposes. Monitor and/or verify externally performed analyses and approve their release;
* Maintain sample custody chain to ensure traceability and reliability of results, as well as adherence to Good Manufacturing Practices;
* Perform microbiological analyses on products, raw materials, environmental samples, and investigational samples;
* Ensure smooth daily laboratory operations and maintenance of the 5S principles;
* Draft, with management support, protocols, reports, procedures, and other quality control-related documentation;
* Propose and document improvements to area-related procedures and collaborate with the Continuous Improvement Program, actively participating in committees when requested;
* Execute tasks inherent to developments (analytical, process-related, supplier-related, etc.) and deviation investigations;
* Conduct routine analyses while ensuring data integrity and assisting in investigations of out-of-specification/out-of-trend results;
* Approve third-party, internal, and system-based test reports;
* Ensure adherence to stability study schedules, environmental monitoring, and other quality control-related studies, as well as execution of associated analyses;
* Maintain laboratory cleanliness and equipment upkeep, and strictly comply with appropriate PPE usage requirements;
* Perform other duties relevant to the position as assigned;
* Carry out responsibilities in compliance with technical, safety, quality, and environmental protection standards and procedures;
* Actively participate in company meetings, commitments, and training sessions when requested;
* Provide operational support to the work area and perform other tasks of similar nature and complexity, or as directed by the immediate supervisor;
* Perform responsibilities in alignment with Maxinutri’s culture and Good Manufacturing Practices to ensure products are manufactured and controlled according to required quality standards;
* Implement actions to ensure food safety per Maxinutri’s culture, applying established Food Defense and Food Fraud standards defined by the Quality department;
* Carry out responsibilities in accordance with the company’s Code of Ethics and Conduct, which establishes internal norms, guidelines, and rules.