QA QMS Lead – Investigations
Overview
The QA QMS Lead – Investigations is responsible for leading and managing the investigation process for quality events such as Out of Specification (OOS), Out of Trend (OOT), Deviations, Complaints, and Non-Conformances.
This individual ensures root causes are properly identified, corrective and preventive actions (CAPA) are implemented effectively, and all quality systems comply with current Good Manufacturing Practices (cGMP) and regulatory requirements.
Responsibilities
Investigations & CAPA
- Lead the site investigation team for OOS, OOT, Deviations, Complaints, and Non-Conformances.
- Conduct thorough root cause analyses and prepare detailed investigation reports.
- Develop, review, and approve CAPA plans to ensure timely and effective resolution of issues.
- Monitor CAPA implementation and track effectiveness to prevent recurrence.
- Partner closely with QA, QC, Operations, Manufacturing, and Engineering departments to gather data and implement corrective actions.
- Communicate investigation findings and follow-up actions to relevant stakeholders.
- Oversee proposed changes to processes, equipment, and systems to ensure they do not adversely affect product quality.
- Conduct and document risk assessments for changes; implement necessary controls in accordance with regulatory standards.
- Maintain and improve QMS processes, procedures, and documentation to ensure consistency and compliance.
- Ensure proper issuance, retrieval, and tracking of QMS documents across the site.
- Resolve findings from internal and external audits and implement corrective actions as required.
- Conduct training sessions on quality standards, investigation procedures, and best practices.
- Maintain updated training records to ensure compliance and employee competency.
- Utilize QMS software such as TrackWise and SAP for managing investigations, CAPAs, and change controls
Education
- Bachelor's degree in Science, Pharmacy, or a related field.
- 5–8 years of relevant experience in pharmaceutical manufacturing, with a focus on Quality Assurance and Quality Management Systems.
- Strong understanding of cGMP, CAPA management, root cause analysis, and change control.
- Proficiency in QMS software (TrackWise, MasterControl, etc.).
- Familiarity with regulatory guidelines such as CDER, ICH, CHRA, and USP Monographs.
- Strong technical writing and documentation skills.
- Ability to make independent decisions regarding investigation outcomes.
- Excellent organizational, analytical, and problem-solving skills.
- Detail-oriented with the ability to work effectively in a cross-functional environment.
- Self-motivated and capable of working independently.
- Working knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.