QC Scientist - Compliance, Investigations & Improvements

Insight Global; Sanford (NC); On-site; USD 80,000 - 110,000; Full time

Job summary

Insight Global is seeking a QC Scientist for a pharmaceutical client in Sanford, NC. The role focuses on supporting cGMP-compliant QC and Stability operations, managing documentation, and driving continuous improvement across QC processes.

The ideal candidate will have strong experience with quality systems, investigations (including OOS), CAPAs, and cross-functional problem solving, plus hands-on knowledge of LIMS, TrackWise, and analytical techniques like HPLC/UPLC and UV-Vis.

Qualifications

• BS/BA in Science or related field with 5 to 7 years biotech/pharmaceutical manufacturing, quality, or engineering experience, or MS with 2 to 4 years.
• Strong understanding of cGMP, Data Integrity, and ALCOA principles.
• Knowledge of US, EU, and ROW cGxP requirements and ICH guidelines.
• Experience with analytical laboratory techniques and equipment including HPLC, UPLC, UV VIS, pH, osmolality, TOC, and conductivity.

Responsibilities

• Support cGMP compliant QC and Stability laboratory operations
• Manage QC documentation, including document requests, reviews, author support, and approvals
• Partner with Document Control, Training, QA, and other cross functional teams
• Support and lead investigations, including events and OOS results
• Analyze, interpret, and trend laboratory data
• Support CAPAs, change controls, risk assessments, and regulatory audits
• Identify documentation and process improvements that strengthen compliance and efficiency
• Troubleshoot issues involving processes, equipment, facilities, utilities, and human performance
• Manage multiple projects and initiatives while meeting established timelines
• Provide guidance, training, and coaching to junior team members

Skills

cGMP compliance

Data integrity

Analytical thinking

Investigations and CAPAs

Education

BS/BA in Science or related field

MS in Science or related field

Tools

LIMS

TrackWise

Quality Change Control

Job description

Insight Global is seeking a QC Scientist for a pharmaceutical client in Sanford, NC. The role focuses on supporting cGMP-compliant QC and Stability operations, managing documentation, and driving continuous improvement across QC processes.

The ideal candidate will have strong experience with quality systems, investigations (including OOS), CAPAs, and cross-functional problem solving, plus hands-on knowledge of LIMS, TrackWise, and analytical techniques like HPLC/UPLC and UV-Vis.