10+ years of experience in QC, enterprise systems, or validation.
Strong analytical skills with a focus on data accuracy and quality.
Ability to create clear local work instructions for global processes.
Familiarity with master data setup and loading.
Proficiency in LIMS or similar data management systems.
Responsibilities
Set up and load local master data according to global guidelines.
Input required master data into the global LIMS system.
Ensure data quality through local data cleansing efforts.
Develop local work instructions for site-level global processes.
Collaborate with teams and work independently with minimal guidance.
Benefits
Opportunities for professional development and training.
Collaborative work environment with an emphasis on teamwork.
Access to cutting-edge technology and systems in laboratory management.
Full Job Description
Job Description:
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
