LIMS Administrator

Job Description

Job Summary:

• Responsible for creating, reviewing, and approving product/master data builds in LIMS per 21CFR Part 11 & EU Annex 11 guidelines and regulations including appropriate data integrity.
• The individual will support OC & QA operational activities by prioritizing data activities, reviewing applicable documentation and making revisions and changes as required.
• Additionally, this individual will act as a software administrator for LIMS software when requested, help define workflow integration of QC processes, including management of user accounts and roles.
• This individual will also assist in the investigation of deviations as needed, managing and executing change controls using Trackwise.

Education:

• BS/BA or MS degree, life sciences preferred.

Experience:

• 3-5 years of GMP experience in pharmaceutical, biopharmaceutical or chemical industry
• Prior experience with analytical testing is preferred.
• Prior data entry experience recommended.
• Requirements:Familiarity with general laboratory instrumentation and documentation.
• Working knowledge of laboratory management systems, LabVantage LIMS preferred.
• Prior Instrumentation testing experience is preferred.
• Able to excel in a team setting in a dynamic environment where shifting priorities are not uncommon.
• Strong verbal and written communication skills.
• Agility to change, quick learner & critical thinking skills desired.