Summary:
This individual is responsible for supporting quality compliance within the QCC group, ensuring quality events and other documents are tracked and closed in a timely manner, including CAPA, SOP updates and audit responses, keeping management informed on quality issues.
Essential Duties:
- Work in a safe manner in accordance with site procedures
- Support quality event writing and closure, both as lead writer and as supporting or reviewing roles
- Perform compendial reviews
- Write, revise and review Standard Operating Procedures, Material Specifications, Forms, Protocols and Reports
- Troubleshoot and recommend process improvements to reduce level of quality events
- Recommend and implement, as required, innovative approaches to problem solving
- Prepare and present study or evaluation summaries as needed
- Manage time effectively
- Support process improvement initiatives, from participation to project lead
- Mentor Chemist I, II and III
- Review and approve data
- Other duties as assigned
Knowledge, skills and abilities:
- Outstanding capabilities for multitasking and adjusting priorities in response to changing conditions and schedules
- Team player with well-developed interpersonal, organizational, and communication skills
- Experience as primary author for quality events
- Ability to handle stressful situations
- Understanding of current Good Manufacturing Practices (cGMPs) with a focus on quality
- Good method validation knowledge
- Good instrument qualification knowledge
- Excellent investigative skills for OOS, OOT and aberrant result laboratory investigations
- Excellent oral and written communication skills.
- Knowledge of data acquisition systems such as Empower CDS
