QC Documentation Scientist

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

Descripción de la vacante

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

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

cGMP knowledge

Data Integrity

ALCOA principles

Project management

Cross-functional problem solving

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

Investigations systems

HPLC

UPLC

UV-Vis

pH

Osmolality

TOC

Conductivity

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 timelines
• Provide 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