Our client, a global biopharmaceutical company that finds and delivers novel treatments for patients with a significant unmet need, has an immediate opening for a Sr. Specialist, QA.

Responsibilities:

• Oversee operations and external quality control laboratories
• Review and approve GMP documents that support qualification of test methods and reference standards, including protocols, data, and reports
• Review and approve laboratory data related to release and stability of GMP materials
• Review electronic records including audit trails
• Collaborate with Quality Control and Analytical Development to support the timely review of documents
• Oversee integrity of data and results generated and external laboratories

Requirements:

• Bachelor’s degree in a scientific discipline with 4+ years of experience in the pharmaceutical/biotech industry in combination with analytical development and quality. Biologics experience is preferred.
• Hands on experience with laboratory testing and method validation
• Familiarity with a wide range of test methods needed for evaluation of diverse samples, such as cell banks, drug substance, drug product, and combination products is a plus
• Excellent verbal and written communication skills
• Strong team player that has a customer service approach and is solution oriented
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors