LIMS Specialist

Position Title: LIMS Specialist

Work Location: Indianapolis, IN

Assignment Duration: 12 Months

Work Schedule: M-F; Standard Hours

Work Arrangement: Onsite

Position Summary: Reporting to the Sr. Manager of Quality Control, LIMS Specialist will be responsible for ensuring the laboratories at our organization's Indianapolis implementation and operation of Veeva LIMS system into our organization's Indianapolis manufacturing plant.

Key Responsibilities:

• Develop LIMS procedures for the laboratories and manufacturing, as needed; develop and maintain documentation for LIMS processes, user guides, and system validation.
• Maintain, configure, and troubleshoot the LIMS to support laboratory workflows and data integrity.
• Serve as the primary point of contact for LIMS-related issues in the laboratories and production, coordinating with IT and laboratory staff for timely resolution.
• Implement system updates, enhancements, and change controls in accordance with regulatory requirements (including, but not limited to, GxP, 21 CFR Part 11).
• Set up studies and sample management protocols in LIMS per laboratory and quality requirements.
• Provide user training and support to laboratory personnel, ensuring effective and compliant use of the LIMS.
• Participate in audits and inspections, providing LIMS data and documentation as required.
• Collaborate with cross-functional teams to support new laboratory initiatives and system integrations.
• Ensure data security, user access management, and backup procedures are in place and effective.
• Support laboratory business continuity and disaster recovery planning as it relates to LIMS.

Qualification & Experience:

• BS in Chemistry, Science, or relevant field with three to five years of experience in pharmaceutical or other cGMP experience. An advanced degree with less experience will be considered provided the LIMS experience requirement can be met.
• One to three years of experience with LIMS system, experience with Veeva LIMS strongly preferred. Experience with other modern LIMS systems preferred (i.e. Labware).
• Experience with injectable pharmaceuticals or radiopharmaceuticals strongly preferred
• Experience with HPLC, TLC, GC, Gamma Spec, and ICP preferred. Experience with at least some laboratory instruments required
• Highly motivated and organized professional with the ability to work independently or in a team environment
• Multi-disciplined scientist with GMP experience
• Experience with root cause techniques such as 6 M's, 5 Why's, fishbone, or similar preferred
• Very personable with strong communication skills
• Excellent professional ethics, integrity, and ability to maintain confidential information
• Must be comfortable working in a controlled environment with ionizing radiation and able to lift 40 lbs.