Lab Data Steward & LIMS Systems Lead

Katalyst-Healthcares-; Portsmouth (NH); On-site; USD 90,000 - 125,000; Full time

Job summary

Creative Solutions Services, LLC seeks an experienced Data Management Specialist to orchestrate local master data setup and loading in a regulated environment. You will manage master data in the global LIMS, ensure data quality, and develop site-specific work instructions aligned with global processes.

Key responsibilities include data cleansing, ensuring regulatory compliance, and collaboration across departments to implement new equipment and processes.

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.
• Ability 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

Responsibilities

• 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.
• Ability to work independently and with the team with little guidance.

Skills

Quality control

LIMS familiarity

Data management

Project management

Planning and organizing

Decision making

Cross-department collaboration

GMP and safety

Education

Bachelor's degree in Science

Tools

Lab Vantage LIMS

TrackWise

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.
• Ability 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.
• Ability 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

• Advanced 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.
• Ability 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