Senior Quality Assurance Specialist - Remote

Overview

As the Senior Quality Assurance Specialist, you will work closely with our CMC team, providing routine QA oversight and support of Contract Manufacturing Organizations and Contract Testing Laboratories for activities including but not limited to manufacturing, qualification/validation, release/stability testing, packaging/labeling and disposition of drug substance and drug product.

In Short

• Provides Quality oversight of CMO operations for drug substance and drug product.
• Ensures compliance to cGMP, policies, and procedures for manufacturing operations.
• Supports disposition activities for Drug Substances and Finished Drug Products.
• Leads evaluations of Investigations/ OOS/ Change Controls.
• Provides Quality oversight of artwork/label review.
• Develops relationships with strategic external partners.
• Conducts ongoing monitoring of regulations.
• Performs assessments and QA review of deviations and investigations.
• Reviews product release and stability data.
• Supports GxP supplier audits.

Requirements

• B.S required in the life sciences or a technical discipline.
• 5+ years of experience in CMC Quality Assurance in the pharma or biotech industry.
• Minimum of 2 years experience working in small-midsize biotechs.
• Experience with biologics preferred.
• Experience conducting batch disposition of GMP materials.
• Knowledge of drug development lifecycle and regulations.
• Strong attention to detail and multitasking ability.
• Excellent communication skills, both written and verbal.

Benefits

• Opportunity to work remotely.
• Potential for contract extension.
• Work with an experienced team in a growing biotech company.
• Engagement in meaningful work that impacts patient lives.