LIMS Master Data Specialist

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps their 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.

Job Title: LIMS Master Data Specialist
Location: Portsmouth, NH 03801
Duration: 10 Months
Job Type: Temporary Assignment
Work Type: Onsite
Shift: 1st Shift

Summary

We are seeking a detail-oriented LIMS Master Data Specialist to support the accurate setup, loading, and maintenance of master data in the global LIMS (gLIMS) environment. This role is responsible for ensuring data integrity, supporting local data management activities, developing site-level work instructions, and maintaining compliance with cGMP, quality, and safety requirements.

Responsibilities

• Perform local master data setup and loading in alignment with global guidelines and data principles.
• Build and maintain master data in the global LIMS system, including consumables, sampling plans, specifications, parameter lists, test methods, and LES templates.
• Conduct local data cleansing activities to ensure data quality and accuracy.
• Develop local work instructions for execution of global processes at the site level.
• Ensure compliance with cGMP requirements during the manufacture and release of APIs.
• Notify management of regulatory inspections, serious GMP deficiencies, process deviations, product defects, and related actions in a timely manner.
• Follow all health, safety, and environmental procedures and participate in required training.
• Promote a safe working environment and comply with company and site safety policies.
• Should adhere to all cGMP, quality, and safety requirements and active participation in maintaining a compliant and safe workplace.

Required Skills

• Bachelor of Science in a science-related discipline or equivalent relevant experience.
• Experience with data management and master data setup/loading processes.
• Experience supporting QC and manufacturing operations in a regulated pharmaceutical or API environment.
• Demonstrated ability to drive continuous improvement, support change initiatives, and collaborate effectively across teams.
• Familiarity with LIMS or similar data management systems.
• Knowledge of QC laboratory operations and related data requirements.
• Understanding of quality systems, including deviations, change controls, CAPAs, OTNs, and TrackWise.
• Familiarity with quality standards, regulatory requirements, and cGMP practices.
• Knowledge of process, equipment, cleaning, and computer system validations.
• Strong attention to detail, analytical thinking, and organizational skills.
• Effective written and verbal communication skills.
• Proficiency in MS Project, Word, Excel, and PowerPoint.
• Ability to manage multiple priorities, work cross-functionally, and support medium to large projects within required timelines.

TekWissen Group is an equal opportunity/affirmative action Employer (m/f/d/v) supporting workforce diversity.