Senior Quality / Deviation Investigation Specialist

QvalFocus Inc.; North Carolina; On-site; USD 110,000 - 140,000; Part time

Job summary

QvalFocus Inc. in North Carolina seeks an experienced Quality professional to support GMP investigations and quality event management in a pharmaceutical manufacturing setting.

You will evaluate deviations, determine root causes, assess impact, and support CAPA activities to ensure timely closure of quality events. The role requires 8+ years in QA, strong root-cause analysis, and excellent technical writing.

Qualifications

• 8+ years of experience in Quality Assurance, deviation investigation, manufacturing quality, or a related pharmaceutical environment; 10+ years preferred.
• Hands-on experience conducting deviation investigations in a GMP manufacturing setting.
• Experience in sterile, biologics, pharmaceutical, or other highly regulated manufacturing environments preferred.
• Working knowledge of root cause analysis, CAPA, quality risk assessment, and investigation documentation.
• Strong technical writing, communication, and cross-functional teamwork skills.
• Ability to work independently, handle multiple investigations, and meet deadlines.

Responsibilities

• Manage and support investigations involving manufacturing deviations, process-related events, equipment, utilities, and quality systems.
• Evaluate event information, batch documentation, manufacturing records, and technical data to identify contributing factors and determine product or process impact.
• Conduct structured root cause analysis using appropriate investigation methods and tools.
• Collaborate with Quality, Manufacturing, Engineering, Validation, Maintenance, and other cross-functional teams to collect information and resolve investigation actions.
• Prepare complete investigation reports documenting the issue, impact assessment, investigation findings, root cause, and corrective actions.
• Assist with CAPA development, effectiveness assessments, and follow-up activities related to investigation findings.
• Examine batch records, equipment logs, maintenance records, and other GMP documentation as needed.
• Monitor investigation timelines, action items, and approvals to support timely closure of quality events.
• Ensure all investigation records meet cGMP, GDP, data integrity, and internal quality system requirements.

Skills

GMP investigations

Deviation investigation

Root cause analysis

Technical writing

Cross-functional teamwork

Project management

Education

Bachelor's degree in a scientific field

Tools

QMS software

Job description

Location: North Carolina

Type: Contract

Duration: Short-Term Project

Industry: Pharmaceutical / Biopharmaceutical Manufacturing

Position Summary

We are looking for an experienced Quality professional to provide support for GMP investigations and quality event management within a pharmaceutical manufacturing environment. The role will focus on evaluating deviations, determining root causes, assessing potential impact, supporting CAPA activities, and ensuring quality investigations are completed accurately and on schedule.

Responsibilities

• Manage and support investigations involving manufacturing deviations, process-related events, equipment, utilities, and quality systems.
• Evaluate event information, batch documentation, manufacturing records, and technical data to identify contributing factors and determine product or process impact.
• Conduct structured root cause analysis using appropriate investigation methods and tools.
• Collaborate with Quality, Manufacturing, Engineering, Validation, Maintenance, and other cross-functional teams to collect information and resolve investigation actions.
• Prepare complete investigation reports documenting the issue, impact assessment, investigation findings, root cause, and corrective actions.
• Assist with CAPA development, effectiveness assessments, and follow-up activities related to investigation findings.
• Examine batch records, equipment logs, maintenance records, and other GMP documentation as needed.
• Monitor investigation timelines, action items, and approvals to support timely closure of quality events.
• Ensure all investigation records meet cGMP, GDP, data integrity, and internal quality system requirements.

Qualifications

• 8+ years of experience in Quality Assurance, deviation investigation, manufacturing quality, or a related pharmaceutical environment; 10+ years preferred.
• Demonstrated hands-on experience conducting deviation investigations in a GMP manufacturing setting.
• Experience in sterile, biologics, pharmaceutical, or other highly regulated manufacturing environments strongly preferred.
• Working knowledge of root cause analysis, CAPA, quality risk assessment, and investigation documentation.
• Strong technical writing, communication, and cross-functional teamwork skills.
• Ability to work independently, handle multiple investigations, and meet established project deadlines.