External Quality Assurance IV - Remote

Overview

The External Quality Assurance IV, Contract Manufacturing Organization (CMO) Product Release role is responsible for the overall quality of biologic products and directly involved with CMO oversight of drug substance, sterile drug product, and finished product manufacturing.

In Short

• Primary Quality point of contact for CMOs.
• Ensures compliance with current good manufacturing practices.
• Acts as a liaison between Quality Assurance and CMO partners.
• Oversees change control implementations at CMOs.
• Supports inspection readiness for CMO activities.
• Coordinates CMO deliverables for Annual Product Review.
• Resolves issues and leads the creation of new systems.
• Maintains a high level of productivity and priority-setting.
• Participates in project teams for personal growth.
• Adheres to all applicable regulations and requirements.

Requirements

• 8+ years of experience in the External Manufacturing biotech/pharmaceutical industry.
• Thorough understanding of drug product manufacturing cGMP requirements.
• Strong critical thinking and problem-solving skills.
• Excellent organizational and prioritization skills.
• Strong written and oral English communication skills.
• Experience with drug and finished product fill finish operations.
• High School Diploma or GED required.
• BA, BS or equivalent degree preferred.
• Lyophilization experience preferred.
• Experience with software applications like Smartsheet and MS Project preferred.

Benefits

• Competitive pay range of $117,000 - $143,000.
• Medical, dental, vision, and life insurance coverage.
• Hybrid or Remote workplace program.
• 401k matching and annual cash bonuses.
• Tuition assistance and pre-IPO options.
• Gym subsidy and wellness programs.
• Generous vacation, sick, and holiday paid time off.
• Paid shutdown between Christmas and New Year’s holidays.
• Casual workplace environment.
• Equal Opportunity Employer.