Key Responsibilities:
- Documentation: Draft and revise procedures to meet regulations, cGMPs, and internal policies.
- Quality Standards: Apply and maintain quality standards and procedures for quality systems.
- cGMP Documentation: Review cGMP documents and lead or participate in their implementation and storage.
- Monitoring: Monitor assigned quality systems and report on their performance.
- Time Management: Operate effectively within strict timelines.
Additional Responsibilities:
- Change Control/Design Control: Oversee and support the process of change control, ensuring clarity, justification, and compliance.
- Risk Management: Assist with scheduling, documentation, and data management for the risk management program.
- Risk Assessment: Participate in risk assessment, including training, categorization, and reporting.
Qualifications:
- Education: Bachelor's degree or equivalent with 2+ years of relevant experience.
- Experience: Independent decision-making in a cGMP environment, writing/reviewing cGMP documents.
- Preferred:
- Understanding of Medical Device/Biologics FDA regulations.
- Knowledge of Trackwise or other quality management systems.
- Risk Management/FMEA experience.
- Project management and statistical skills.
- Regulatory inspection SME experience.
- Group presentation and cross-functional influence experience.
- Strong communication skills.
