QC Scientist

Required Skills & Experience

• BS/BA in Science or related field with 5 to 7 years of biotech/pharmaceutical manufacturing, quality, or engineering experience, or MS in Science or related field with 2 to 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; the source specifically references Method 1/Yellow Belt training and tools

Job Description

Our pharmaceutical client is looking for a QC Scientist to support their Quality Operations at their manufacturing site in Sanford, NC. This role will primarily be focused on QC standards, controls, documentation, compliance, investigations, and continuous improvement. This individual will work independently and cross functionally to maintain compliant QC and Stability laboratory operations.

Key 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