Position Summary
The Manufacturing QMS Associate supports Quality Management System (QMS) activities by managing change controls, deviations, CAPAs, investigations, SOP documentation, and continuous improvement initiatives while ensuring compliance with quality and regulatory requirements.
Key Responsibilities
QMS & Documentation
- Initiate and review Change Controls, Deviations, and CAPAs through Master Control.
- Draft investigations, including OOS and deviation reports.
- Prepare and maintain Standard Operating Procedures (SOPs).
Cross-Functional Support
- Coordinate with cross-functional teams for timely completion of QMS activities.
- Collaborate with the Quality team for document review and approval.
- Provide training on cleanroom requirements and manufacturing practices.
Continuous Improvement
- Support process improvement initiatives.
- Perform additional duties assigned by the HOD based on organizational needs.
Qualifications
Required
- Bachelor's degree in Pharmacy, Life Sciences, Biotechnology, or related field.
- 2-4 years of experience in Quality Systems, Manufacturing, or GMP-regulated environments.
- Experience with Change Control, CAPA, Deviations, and SOP documentation.
Preferred
- Experience with MasterControl or equivalent electronic QMS.
- Knowledge of GMP, FDA, and quality compliance requirements.
Key Competencies
- Quality Management Systems (QMS)
- Change Control Management
- CAPA & Deviation Handling
- Investigation Writing
- SOP Development
- GMP Compliance
- Documentation Management
- Process Improvement
- Cross-Functional Collaboration
- Attention to Detail
What Success Looks Like
- QMS records are completed accurately and on time.
- Investigations, CAPAs, and change controls are well-documented and compliant.
- SOPs and quality documents are maintained effectively.
- Continuous improvement initiatives enhance compliance and operational efficiency.
