Laboratory Information Management System Specialist - Berkeley, CA

Bayer•Berkeley, CA

7d•$96,480 - $144,720•Onsite

About The Position

As a LIMS Specialist, you will oversee the organization's data assets to ensure their quality, integrity, and compliance with relevant standards and regulations. This role involves establishing and enforcing data governance policies, maintaining data dictionaries, and monitoring data management practices across departments. Collaborating with stakeholders, you will define data requirements, resolve data issues, and promote best practices for data usage. Acting as a liaison between technical teams and business units, you ensure that data is accurate, accessible, and effectively utilized to support organizational goals. You will be responsible for translating laboratory testing procedures and business processes into compliant and robust LabVantage LIMS master data. Partnering with Quality stakeholders, you will implement, validate, and continuously improve LIMS master data to increase laboratory efficiency through digital solutions in support of cGMP-compliant drug product testing. Additionally, you will uphold data-integrity requirements, including 21 CFR Part 11, and support computerized system validation, change management, troubleshooting, and harmonization of laboratory data standards.

Requirements

Bachelor of Science Degree in Computer Science, Science, or related discipline;
BS with 6+ years of industry experience, or MS with 2+ years of industry experience, or an equivalent combination of education and experience;
Excellent knowledge of LabVantage LIMS (version 8 or above) and MODA, including master data and roles & authorization concepts;
Software/LIMS validation experience;
Experience working in a cGMP and global regulatory compliance organization;
Ability to multi-task and adapt to changing business requirements in a dynamic corporate environment.

Nice To Haves

Programming experience in Java or Python;
Experience with LabVantage SDMS or ELN/LES;
Familiarity with Bayer products and manufacturing processes.

Responsibilities

Design, develop, and test LabVantage LIMS and MODA Master Data in alignment with cGMP, data integrity, and 21 CFR Part 11 requirements;
Support implementation of digital solutions in pharmaceutical laboratory environments, including Instrument Integration and setup of Electronic Lab Notebook;
Support user account management for LIMS and MODA systems and perform regular user access reviews in collaboration with business process owners;
Drive continual improvement by regularly evaluating improvement opportunities in existing SOPs or protocol deviations;
Support Deviation investigations and CAPA implementation as needed;
Interact with peers, department management, and internal departments (QA, QC, Manufacturing);
Collaborate and exchange with LIMS and MODA master data managers from supply centers globally;
Communicate effectively and promptly at all levels of the organization, supporting department objectives and management decisions.