QC LIMS Specialist

SOKOL GxP Services is seeking a skilled LIMS Specialist to support the implementation and ongoing operation of Veeva LIMS at the RayzeBio (a Bristol Myers Squibb company) manufacturing plant in Indianapolis, IN. As a trusted partner to life sciences organizations, SOKOL GxP Services delivers tailored CQV and compliance solutions, ensuring product quality and patient safety through rigorous regulatory adherence and technical excellence. This role is critical to maintaining laboratory and manufacturing data integrity, supporting business continuity, and enabling compliant operations in a fast-paced pharmaceutical environment.

Key responsibilities include:

• Developing and maintaining LIMS procedures, documentation, and user guides for laboratory and manufacturing workflows.
• Configuring, troubleshooting, and supporting the LIMS to ensure seamless operations and data integrity.
• Serving as the primary point of contact for LIMS-related issues, collaborating with IT, laboratory, and production staff.
• Implementing system updates, enhancements, and change controls in accordance with regulatory requirements (GxP, 21 CFR Part 11).
• Setting up studies and sample management protocols within the LIMS platform.
• Training and supporting end-users to ensure compliant and effective LIMS utilization.
• Providing LIMS data and documentation during audits and inspections.
• Collaborating cross-functionally on laboratory initiatives and system integrations.
• Ensuring data security, access management, and regular backups for the LIMS environment.
• Supporting business continuity and disaster recovery planning related to LIMS operations.

Requirements:
Required Qualifications:

• Bachelor’s degree in Chemistry, Science, or a related field;
• 3–5 years of experience in a pharmaceutical or cGMP-regulated environment;
• 1–3 years of hands-on experience supporting or administering a modern LIMS platform (Veeva LIMS strongly preferred; LabWare or similar acceptable);
• Hands-on experience using at least one laboratory instrument or technique (HPLC, TLC, GC, Gamma Spec, or ICP);
• Experience working under GMP/GxP requirements, including 21 CFR Part 11 for electronic records and signatures;
• Comfortable working in controlled environments with ionizing radiation;
• Able to lift 40 lbs;
• Authorized to work in the United States.

Preferred Qualifications:

• Advanced degree in Chemistry, Science, or a related field.
• Experience in injectable pharmaceuticals or radiopharmaceuticals.
• Experience applying root cause analysis techniques (such as 5 Whys, fishbone/Ishikawa, or 6Ms).
• Strong organizational skills and ability to work independently or collaboratively.
• Excellent written and verbal communication skills.
• High ethical standards and demonstrated confidentiality.

Benefits:
Competitive hourly rate: $56.83 – $69.33/hr (W-2 only, no C2C)

Working Hours: Monday - Friday, regular business hours

12-month contract with possible extension

Health insurance, holiday pay, 401(k) program, and other benefits

Employee referral bonus program