MFG Documentation Associate (Lighthouse)
Location - Chandler, AZ
Job Description
Position Summary
The Manufacturing Documentation Associate (Lighthouse) supports environmental monitoring, manufacturing documentation, audit readiness, and coordination of manufacturing activities while ensuring GMP compliance and operational efficiency.
Key Responsibilities
Documentation & Monitoring
- Monitor environmental conditions through Lighthouse during manufacturing activities.
- Document and review Lighthouse alarms and batch printouts.
- Issue, review, and maintain manufacturing documents, logbooks, and forms.
Manufacturing Support
- Coordinate documentation for visual inspection and packaging operations.
- Support departmental training activities.
- Perform assigned tasks as directed by the HOD.
Compliance & Audit Readiness
- Conduct GEMBA walks and maintain audit readiness across manufacturing lines.
- Ensure documentation complies with manufacturing and quality requirements.
Qualifications
Required
- Bachelor's degree in Pharmacy, Life Sciences, Biotechnology, or related field.
- 1-3 years of experience in pharmaceutical manufacturing or documentation.
- Strong organizational skills and attention to detail.
Preferred
- Experience with environmental monitoring systems.
- Knowledge of GMP documentation and audit requirements.
Key Competencies
- Environmental Monitoring
- Documentation Management
- GMP Compliance
- Audit Readiness
- Attention to Detail
- Organization & Planning
- Training Coordination
- Team Collaboration
What Success Looks Like
- Environmental monitoring and documentation are completed accurately and on time.
- Manufacturing records remain audit-ready and compliant.
- Visual inspection and packaging documentation are effectively coordinated.
- Manufacturing areas consistently meet inspection and compliance standards.
