Laboratory Information Management System Specialist - Berkeley, CA

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., * 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.

• 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.

Preferred Qualifications:

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

Employees can expect to be paid a salary between $96,480.00 - $144,720.00. Additional compensation may include a bonus or commission (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc., Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Health for all, Hunger for none, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer.

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ‘Health for all Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice., To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

Bayer is an Equal Opportunity Employer/Disabled/Veterans

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