LIMS Data Specialist (contract)

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

Pay Rate: $58.00–$76.00/hour

Schedule: 1st Shift, 8:00 AM–4:30 PM EST

Location: Swiftwater, PA – Onsite

Sanofi's contingent workforce program, FLEXT Direct, is seeking a LIMS Data Specialist for a 3-month contract supporting Quality Operations at the Swiftwater site.

LIMS Data Specialist

Pay Rate: $58.00–$76.00/hour

Schedule: 1st Shift, 8:00 AM–4:30 PM EST

Location: Swiftwater, PA – Onsite

Sanofi's contingent workforce program, FLEXT Direct, is seeking a LIMS Data Specialist for a 3-month contract supporting Quality Operations at the Swiftwater site.

Position Overview

The Lab Information Management System (LIMS) Business Administrator is essential to Quality Operations at the Swiftwater site, supporting the maintenance and improvement of the LIMS system.

Responsibilities include supporting the business by updating master data for new and existing products and analyses, maintaining system documentation, and providing ad hoc support to other departments.

The role will also support the creation and updating of master data, including Product Specifications, Item Codes, and Sampling Plans, in support of data remediation and SPC projects.

Position 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.

Technical Competencies & Soft Skills

• Working knowledge of aseptic processes, biology, chemistry, or life sciences.
• Knowledge of cGMPs and applicable regulatory requirements.
• Strong analytical and balanced decision-making skills.
• Excellent written and verbal communication skills.
• Ability to lead and participate effectively in teams.
• Experience working in a laboratory environment.

Basic Requirements

• 1–3 years of experience using and administering LabWare LIMS, including LIMS Basic.
• Strong working knowledge of laboratory processes, including cGMPs, in a pharmaceutical environment.
• Experience with system validation and master data management.
• Familiarity with 21 CFR Part 11 data-integrity best practices in a pharmaceutical environment.
• Excellent written and verbal communication skills and the ability to lead and participate in teams.
• Experience or familiarity with the laboratory environment.