LIMS Master Data Analyst

Unicon Pharma Inc; Portsmouth (NH); On-site; USD 80,000 - 110,000; Full time

Job summary

Unicon Pharma Inc in Portsmouth, NH seeks a Master Data Specialist to load and maintain master data in gLIMS per global guidelines, ensuring data integrity and local support for ongoing data management.

Responsibilities include local data setup, inputting master data into the global LIMS, data cleansing, and drafting local work instructions; familiarity with TrackWise and QC regulatory requirements is preferred.

Qualifications

• Bachelor's degree in science or related field.
• Experience in data management and master data loads.
• Strong attention to detail and data quality.
• Ability to develop clear local work instructions.
• Knowledge of QC lab operations and data requirements.

Responsibilities

• Perform local master data setup and load in alignment with global guidelines.
• Input all initial master data into the global LIMS, including consumables, sampling plans, specifications, parameter lists, test methods, and LES templates.
• Conduct local data cleansing to ensure data quality.
• Develop local work instructions detailing execution of global processes at site level.
• Proficiency in using LIMS or similar systems and familiarity with quality standards and regulatory requirements.

Skills

Quality control

TrackWise

GMP compliance

Project management

Planning & organizing

Decision making

Interdepartmental collab

GMP & Safety

Technical writing

MS Office

Education

Bachelor of Science

Tools

TrackWise

Job description

• 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 LIMS or similar systems and familiarity with quality standards and regulatory requirements.

Degree (required)*: Bachelor of Science(Science related discipline or relevant experience in the field)

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


• Strong written and verbal communication skills


• Ability to work in MS Project, Word, Excel, PowerPoint