LIMS Master Data Specialist – cGMP Focus

Sanofi; Swiftwater (Monroe County); On-site; USD 80,000 - 105,000; Full time

Job summary

Sanofi's FLEXT Direct program seeks a LIMS Data Specialist for a 3-month contract to support Quality Operations at the Swiftwater site. The role focuses on maintaining the LIMS, updating master data for products and analyses, and ensuring compliance with relevant regulations.

The position requires 1–3 years of LIMS experience, familiarity with cGMPs and 21 CFR Part 11, and strong communication skills. Onsite shift is 8:00 AM–4:30 PM EST in Swiftwater, PA.

Qualifications

• Experience with LabWare LIMS administration and LIMS Basic.
• Strong working knowledge of laboratory processes and cGMPs in a pharmaceutical setting.
• Familiarity with 21 CFR Part 11 data integrity practices.
• Excellent written and verbal communication skills and ability to lead and participate in teams.

Responsibilities

• Ensure on-time implementation of data remediation activities through support of master data configuration, data migration, and SOP revisions.
• Support the master data management process, including updating specifications and analyses and supporting the approval and verification process.
• Ensure that the LIMS complies with relevant regulatory standards.
• Support the business in creating and updating training materials as system changes occur.

Skills

LabWare LIMS

LIMS Basic

21 CFR Part 11

cGMPs

Regulatory compliance

Written & verbal communication

Team collaboration

Laboratory environment

Job description

Sanofi's FLEXT Direct program seeks a LIMS Data Specialist for a 3-month contract to support Quality Operations at the Swiftwater site. The role focuses on maintaining the LIMS, updating master data for products and analyses, and ensuring compliance with relevant regulations.

The position requires 1–3 years of LIMS experience, familiarity with cGMPs and 21 CFR Part 11, and strong communication skills. Onsite shift is 8:00 AM–4:30 PM EST in Swiftwater, PA.