As Lead QA Technician, you ensure product quality and regulatory compliance within pharmaceutical manufacturing. You will work as part of the Quality team to uphold high standards and support life-changing medicines. Expect to investigate deviations, manage CAPA, and help prepare for regulatory inspections in an aseptic environment. You will collaborate with cross-functional teams to maintain compliant documentation and processes, contributing to the mission of making the world healthier, cleaner and safer. This role offers the chance to shape quality programs in a global, fast-paced setting.
- Quality oversight of pharmaceutical manufacturing operations
- Batch record review and deviation investigations
- CAPA management and effectiveness verification
- Support regulatory inspections and customer audits
- Maintain and improve quality systems and documentation (TrackWise, Documentum)
- Collaborate with cross-functional teams to address quality issues
- Ensure aseptic manufacturing processes and clean room controls
- Communicate findings clearly and drive corrective actions
- Guide and develop team members on quality practices
- Manage multiple priorities in a dynamic environment
- 4 years of experience in pharmaceutical quality assurance or related GMP environment
- Comprehensive knowledge of GMP regulations, FDA guidelines and quality systems
- Experience with batch record review, deviation investigations and CAPA management
- Strong understanding of aseptic manufacturing processes and controls
- Advanced proficiency in quality documentation systems (e.g. TrackWise, Documentum)
- Professional communication skills (written and spoken)
- Ability to manage multiple priorities and work under pressure
- Strong attention to detail and analytical problem-solving skills
- Interpersonal and communication abilities; project management and organizational capabilities
- Experience supporting regulatory inspections and customer audits
- Cross-functional team collaboration
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