QC Scientist: Stability Lab & Investigations

Insight Global; Sanford (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

Insight Global is seeking a QC Scientist for a pharmaceutical client at the Sanford, NC site. The role focuses on QC standards, controls, documentation, compliance, investigations, and continuous improvement within QC and Stability labs.

The candidate will work independently and cross-functionally to maintain compliant laboratory operations, support investigations, trend data, and drive CAPAs, change controls, and regulatory audits. Strong knowledge of cGxP and analytical techniques is required.

Qualifications

• BS/BA in Science or related field with 5–7 years in biotech/pharmaceutical manufacturing, quality, or engineering experience.
• MS in Science or related field with 2–4 years of relevant experience.
• Strong understanding of cGMP, Data Integrity, and ALCOA principles.
• Knowledge of US, EU, and ROW cGxP requirements and ICH guidelines.
• Experience with LIMS, TrackWise, Quality Change Control, investigations, and documentation systems.
• Knowledge of analytical laboratory techniques and equipment including HPLC, UPLC, UV Vis, pH, osmolality, TOC, and conductivity.
• Experience with project management, continuous improvement, and cross-functional problem solving.
• Lean Six Sigma knowledge preferred; Method 1/Yellow Belt training and tools.

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 & ALCOA

Data Integrity

LIMS

TrackWise

Quality Change Control

Analytical Techniques

Project Management

Lean Six Sigma (Yellow Belt)

Education

BS/BA in Science or related field

MS in Science or related field

Tools

LIMS

TrackWise

Quality Change Control system

Job description

Insight Global is seeking a QC Scientist for a pharmaceutical client at the Sanford, NC site. The role focuses on QC standards, controls, documentation, compliance, investigations, and continuous improvement within QC and Stability labs.

The candidate will work independently and cross-functionally to maintain compliant laboratory operations, support investigations, trend data, and drive CAPAs, change controls, and regulatory audits. Strong knowledge of cGxP and analytical techniques is required.