Description

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

Qualifications

• Bachelor’s in Chemistry or related field with at least 6 years pharmaceutical industry experience
• Knowledge of cGMP and ICH regulatory requirements
• Good interpersonal skills and the ability to work well in a team environment
• Enthusiasm for building a company with outstanding work ethic; must be able to perform in a fast-paced multiproduct environment
• Qualified to work with controlled substances