IN 2024, EUROFINS GENERATED TOTAL REVENUES OF EUR 6.515 BILLION, AND HAS BEEN AMONG THE BEST PERFORMING STOCKS IN EUROPE OVER THE PAST 20 YEARS.

Job Description
This position is responsible for managing, controlling and maintaining the stability database and stability sample distribution; the review, inventory and accuracy of all standards, reagents and chromatographic columns as per the laboratory Quality Systems in compliance with cGMP and ISO 17025:2017 requirements.

KEY SKILLS, EXPERIENCE & ABILITIES:

• Knowledge of GMP and ISO 17025 requirements;
• +3 years of experience in a QA role/ GMP or ISO17025 environment;
• Must speak and write English fluently;
• Must possess excellent communication skills, both written and verbal;
• Excellent organizational skills;
• High level of accuracy and strong attention to detail;
• Ability to work independently, while supporting a collaborative, team-based department;
• Ability to multitask and remain calm under pressure;
• High level of professionalism, maturity, good judgment, and discretion when dealing in confidential matters;
• Exceptional computer skills with a high level of competence with MS Office (Outlook, Word, Excel);
• Must be proactive, self-disciplined, and able to demonstrate a high level of productivity;
• Demonstrate satisfactory work performance and attendance record;
• Willingness to learn with the ability to retain information quickly and apply knowledge to various scenarios.

EDUCATION

• Degree or diploma in a science-related discipline;

• Receive new stability samples for testing, logging sample information and inventory accurately into the database, ensuring samples are stored in the correct stability conditions;
• Ensure stability chambers, ovens and rooms are clean and organized;
• Maintain stability database (inventory, date changes, other pertinent information); removing products at appropriate pull date and disposing of remaining inventory when appropriate;
• Prepare protocols based and trending reports based on clients’ requirements;
• Create and update templates in software, scanning and uploading documentation as needed;
• Proactively communicate with clients and other team members internally regarding the correct specifications that templates must abide by;
• Audit samples and studies as needed, verifying that they comply with in-house administrative requirements, methodology and SOPs;
• Enter all standards, reagents and columns as well as associated documentation (certificates of analysis/compliance and SDS) into the database system;
• Perform monthly checks and remove materials from laboratory that are going to expire within the next month, communicate with laboratory or clients (for client standards, communication will begin two (2) months priory to expiry);
• Collect expired standards and reagents from laboratories for disposal and removal from database;
• Follow Compendial updates and update the system accordingly with regards to expiration dates;
• Prepare re-evaluation and re-standardization documentation;
• Update standard and reagent information in the database after re-evaluation and re-standardization, filing the associated reports;
• Approve Certificates of Analysis of standards (Primary, Secondary and Client);
• Assist with the procurement of new standards, reagents and columns;
• File, scan, organize, store and maintain documentation as well as other administrative responsibilities;
• Attend staff meetings;
• Support the training of new staff;
• Any other duties as delegated by the Department Head or designated.
  Qualifications