Quality Control Scientist

Insight Global; Sanford (NC); Presencial; USD 90.000 - 120.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

cGMP & ALCOA

Data Integrity

LIMS

TrackWise

Quality Change Control

Analytical Techniques

Project Management

Lean Six Sigma (Yellow Belt)

Educación

BS/BA in Science or related field

MS in Science or related field

Herramientas

LIMS

TrackWise

Quality Change Control system

Descripción del empleo

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 timelinesProvide guidance, training, and coaching to junior team members

Qualifications

• 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

Ideal Background

A strong candidate will have hands on pharmaceutical or biotech QC experience combined with strong documentation and quality systems knowledge. They should be comfortable working across QC, QA, manufacturing, engineering, EHS, and MS&T and independently driving investigations, documentation improvements, and compliance related initiatives.