Job Description

Position: Quality Control Specialist
Location: Indiana, United States
Industry: Pharmaceutical Manufacturing

Experience: 5 - 8 Years
Employment Type: Contract

We are seeking a Quality Control Specialist to join the QC team at their new gene therapy manufacturing site (scheduled to be operational in 2026). This role focuses on QC data management to support both internal and external manufacturing of advanced therapeutic medicinal products .

The QC team anticipates a significant increase in data volume, and this role is critical in ensuring accurate data tracking, compliance with GMP, and on-time delivery of testing results. You will work closely with QC Subject Matter Experts (SMEs) to streamline data processes and implement paperless Electronic Lab Notebook (ELN) solutions.

Data Management & QC Support

• Support QC operations for both internal and external manufacturing.

• Partner with QC SMEs to manage and track all QC data.

• Create, manage, and maintain ELN templates for QC testing.

• Develop and maintain systems for incoming QC data, sample/result tracking, and reporting.

Data & Documentation

• Author, compile, and review QC-related data, including:

  • Sample Test Requests for third-party testing

  • Sample Results, Certificates of Analysis (COAs), Certificates of Testing (COTs)

  • Stability Analysis Reports

  • QC Data Trending Reports and Testing Progress Trackers

  • QC/Sample Deviation Tracking Logs

• Manage sample shipments, including requests and tracking.

• Maintain and verify ELN and LIMS master data (equipment, consumables, reagents, reference standards).

Compliance & Process Improvement

• Ensure accuracy and compliance of QC data per GMP standards.

• Develop and update Standard Operating Procedures (SOPs) for QC data management.

• Oversee ELN template creation/review/approval timelines.

• Participate in meetings with internal teams and external manufacturing partners to provide oversight and ensure data integrity.

• Bachelor's degree in Biology, Biological Sciences, BioEngineering , or related field.

• Substantial experience in pharmaceutical manufacturing and GMP systems .

• Strong biologics experience (gene therapy experience preferred).

• Previous experience in a QC laboratory managing QC data.

• Strong oral, written, and presentation communication skills.

• Certification in Quality Control or Quality Management (ASQ, Six Sigma, etc.).

• Experience with advanced therapies or gene therapy manufacturing/QC.

• Hands-on experience with ELN or LIMS systems.

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