LIMS Master Data Specialist

TekWissen ®; Portsmouth (NH); Presencial; USD 41.000 - 48.000; Jornada completa

Descripción de la vacante

TekWissen Group is seeking a QC data specialist to manage master data for the global Laboratory Information Management System (gLIMS) implementation. You will work with QC SMEs and project teams to ensure accurate data migration, site go-live readiness, and ongoing data integrity throughout the project lifecycle.

The role requires a science background and experience with LIMS, data management, and regulatory requirements.

Formación

• Bachelor's degree in a science-related discipline or equivalent relevant experience.
• 0–4 years of relevant experience in data management, master data setup, data cleansing, validation, or data loading.
• Experience with LIMS or similar enterprise data management systems.
• Knowledge of QC laboratory operations and associated data requirements.
• Understanding of cGMP requirements, quality standards, data integrity, and regulated laboratory environments.

Responsabilidades

• Perform local master data setup and loading in alignment with global guidelines and data governance principles.
• Create and load required master data into the global LIMS, including consumables, sampling plans, specifications, parameter lists, test methods, and LES templates.
• Conduct data cleansing and validation to ensure accuracy, completeness, consistency, and quality.
• Collaborate with QC SMEs and project teams to support data migration, issue resolution, and go-live readiness.
• Develop and maintain site-specific work instructions for executing global processes at the local level.
• Ensure compliance with applicable cGMP requirements, quality standards, regulatory guidelines, and data integrity principles.
• Support quality documentation, validation activities, and established procedures throughout project execution.
• Work cross-functionally to communicate progress, resolve data discrepancies, and support continuous improvement initiatives.
• Prioritize assigned tasks, meet project timelines, and elevate data quality or compliance issues as needed.
• Follow company quality and safety policies and promptly report potential compliance deficiencies, deviations, and safety concerns.

Conocimientos

Data management

Master data setup

Data cleansing

Data validation

LIMS experience

cGMP knowledge

QC lab operations

Documentation

TrackWise

Data integrity

Educación

Bachelor's degree in science

Herramientas

LIMS

TrackWise

MS Project

Microsoft Excel

Microsoft Word

PowerPoint

Descripción del empleo

Pay Rate:

$30 to $35 - Depending on experience

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients worldwide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps its customers deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, bioscience, biopharmaceuticals, custom manufacturing, biotechnology, life science ingredients, nutrition, microbial control, agriculture, materials science, personal care, and cell and gene therapy.

Note:

Applicants must be currently authorized to work full-time in the United States for any employer. This role does not offer visa sponsorship, now or in the future, and only W2 candidates will be considered for this position

Summary:

Responsible for the preparation, cleansing, validation, loading, and ongoing maintenance of Quality Control (QC) master data for global Laboratory Information Management System (gLIMS) implementation. Collaborates with QC Subject Matter Experts (SMEs) and project teams to ensure accurate, complete, and compliant data migration, support site go-live readiness, and maintain data integrity throughout the project lifecycle.

Responsibilities:

• Perform local master data setup and loading in alignment with global guidelines and data governance principles.
• Create and load required master data into the global LIMS, including consumables, sampling plans, specifications, parameter lists, test methods, and Laboratory Execution System (LES) templates.
• Conduct data cleansing and validation to ensure accuracy, completeness, consistency, and quality.
• Collaborate with QC SMEs and project teams to support data migration, issue resolution, and go-live readiness.
• Develop and maintain site-specific work instructions for executing global processes at the local level.
• Ensure compliance with applicable cGMP requirements, quality standards, regulatory guidelines, and data integrity principles.
• Support quality documentation, validation activities, and established procedures throughout project execution.
• Work cross-functionally to communicate progress, resolve data discrepancies, and support continuous improvement initiatives.
• Prioritize assigned tasks, meet project timelines, and elevate data quality or compliance issues as needed.
• Follow company quality and safety policies and promptly report potential compliance deficiencies, deviations, and safety concerns.

Required Skills:

• Bachelor's degree in a science-related discipline or equivalent relevant experience.
• 0-4 years of relevant experience in data management, master data setup, data cleansing, validation, or data loading.
• Experience with LIMS or similar enterprise data management systems.
• Knowledge of QC laboratory operations and associated data requirements.
• Strong attention to detail and analytical skills to ensure data accuracy, consistency, and integrity.
• Understanding of cGMP requirements, quality standards, data integrity, and regulated laboratory environments.
• Familiarity with enterprise systems, quality management systems, and validation processes.
• Knowledge of deviations, change controls, CAPAs, and related quality processes; experience with TrackWise or similar systems is beneficial.
• Ability to develop clear, concise work instructions and technical documentation.
• Proficiency in Microsoft Word, Excel, PowerPoint, and MS Project.
• Strong planning, organizational, problem-solving, and decision-making skills.
• Effective written and verbal communication skills, with the ability to collaborate across cross-functional teams.
• Ability to adapt to changing requirements, support system implementation, and contribute to continuous improvement.
• Demonstrates accountability, integrity, commitment to quality, and adherence to workplace safety requirements.

TekWissen® Group is an equal opportunity employer supporting workforce diversity.