QC Documentation Scientist - cGMP & Investigations Lead

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

Job summary

Insight Global represents a pharmaceutical client seeking a QC Scientist to support Quality Operations at a Sanford, NC manufacturing site. The role emphasizes QC standards, controls, documentation, compliance, investigations, and continuous improvement, working independently and with cross-functional teams to maintain compliant QC and Stability labs.

The candidate will handle cGMP compliant QC activities, document control, data analysis, CAPAs, and audits, while mentoring junior staff and

Qualifications

• BS/BA in Science or related field with 5–7 years 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 and ICH guidelines.
• Experience with LIMS, TrackWise, Quality Change Control, investigations, and documentation systems.
• Knowledge of analytical lab techniques and equipment including HPLC, UPLC, UV Vis, pH, osmolality, TOC, and conductivity.
• Experience with project management, continuous improvement, cross functional problem solving.
• Lean Six Sigma knowledge preferred; Yellow Belt training referenced.

Responsibilities

• Support cGMP compliant QC and Stability laboratory operations.
• Manage QC documentation, including requests, reviews, author support, and approvals.
• Partner with Document Control, Training, QA, and 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 to strengthen compliance and efficiency.
• Troubleshoot issues involving processes, equipment, facilities, utilities, and human performance.
• Manage multiple projects and initiatives while meeting timelines.
• Provide guidance, training, and coaching to junior team members.

Skills

cGMP knowledge

Data Integrity

ALCOA principles

Project management

Cross-functional problem solving

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

Investigations systems

HPLC

UPLC

UV-Vis

pH

Osmolality

TOC

Conductivity

Job description

Insight Global represents a pharmaceutical client seeking a QC Scientist to support Quality Operations at a Sanford, NC manufacturing site. The role emphasizes QC standards, controls, documentation, compliance, investigations, and continuous improvement, working independently and with cross-functional teams to maintain compliant QC and Stability labs.

The candidate will handle cGMP compliant QC activities, document control, data analysis, CAPAs, and audits, while mentoring junior staff and