Summary: Responsible for the accurate setup and loading of master data into the gLIMS according to global guidelines and data principles. This role plays a crucial part in ensuring data integrity and establishing local support structures for ongoing data management.
Key Accountabilities: - Perform local master data setup and load in alignment with global guidelines and data principles.
- Build and input all initially required master data into the global LIMS system, including consumables, sampling plans, specifications, parameter lists, test methods, and LES templates.
- Conduct local data cleansing to ensure data quality and accuracy.
- Develop local work instructions to detail the execution of global processes at site level.
- Proficiency in using Lab Vantage LIMS or similar systems and familiarity with quality standards and regulatory requirements.
- bility to work independently and with the team with little guidance.
Qualifications: - Experience in data management and familiarity with master data setup and loading processes.
- Strong attention to detail and analytical skills to ensure data accuracy and quality.
- bility to develop clear and concise local work instructions.
- Knowledge of QC lab operations and related data requirements.
- Proficiency in using LIMS or similar data management system
Skills: - dvanced technical knowledge of Quality control and manufacturing operations.
- Working knowledge and experience with Quality Systems including deviations, change controls, CAPAs, OTNs, deviations; both the system (TrackWise) and the practical applications in operations
- Knowledgeable in process, equipment, cleaning, and computer system validations to the extent of being able to effectively review and approve protocols and reports and support implementation of new equipment.
- Demonstrated ability to manage medium to large sized projects within required timeframes.
- Demonstrate ability for effective Planning, Organizing and Controlling competency
- Demonstrate sound decision making.
- bility to work inter-departmentally and with customers.
- Demonstrates role model behaviors for GMP and Safety behaviors
Education: - Bachelor of Science, Science related discipline or relevant experience in the field.
Work Experience: - QC, Enterprise systems, Validation, Highly Experienced - 10+ years
