Quality Control Specialist (Raw Materials) - Remote

Overview

The Quality Control Specialist (Raw Materials) will develop raw materials strategy, harmonizing raw materials requirements and incoming testing approaches across external manufacturing sites and overseeing vendor material change notification. This role will also contribute to developing systems and procedures, building relationships with our CMO network, and serving as a subject matter expert (SME) for raw materials.

In Short

• Develop raw materials control strategy.
• Maintain raw materials specifications.
• Facilitate technical review of EBRs.
• Contribute to CMC regulatory submission processes.
• Manage CMOs Vendor Change Notification.
• Support cross-functional teams for vendor issues.
• Lead strategic QC activities related to raw materials.
• Ensure GxP and SOP training tasks are completed.
• This position may require travel (approximately 5%).

Requirements

• BS or MS in Chemistry, Biochemistry, Microbiology, Biology, or related field.
• 5+ years of experience in biopharmaceutical industry.
• Knowledge of cGMP/ICH/FDA/EU/PMDA regulations.
• Knowledge of USP, EP, and JP monographs.
• Collaborative team player with strong communication skills.
• Self-directed with ability to work in a fast-paced environment.
• Ability to organize data and identify gaps.
• Knowledge of Good Manufacturing Practices.
• Experience managing CMO relationships is a plus.
• Understanding of statistical methods/tools.

Benefits

• Base salary range of $104,500 - $115,500.
• Competitive compensation and benefits including bonuses and stock options.
• 401(k) with employer match.
• Comprehensive wellness program.
• Commitment to learning and development opportunities.