Laboratory Systems Administrator

Katalyst CRO; Portsmouth (NH); On-site; USD 90,000 - 130,000; Full time

Job summary

Katalyst CRO in Portsmouth, NH seeks a data management specialist to perform local master data setup, load master data into the global LIMS, and ensure data quality and compliance with quality standards and regulatory requirements.

The role involves developing local work instructions and working both independently and with a team to implement global processes at the site level.

Qualifications

• Experience in data management and master data loading processes.
• Strong attention to detail and analytical skills to ensure data accuracy.
• 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 systems experience

Project management

Planning and organizing

Decision making

Inter-department collaboration

GMP and safety behaviors

Education

Bachelor of Science, science-related field

Tools

LIMS (LabVantage)

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