Job Title: Quality Control Scientist - Analytical

Job Description

This role involves conducting QC analysis of raw materials, in-process samples, drug substances, and drug product samples to support GMP manufacturing operations at facilities located in Seattle and Redmond, WA. The position plays a critical role in ensuring the quality of biotherapeutic products.

Responsibilities

• Perform routine and non-routine QC testing using chromatographic and physiochemical methods.
• Ensure timely and accurate completion of GMP documentation.
• Collaborate with Analytical Development to generate and approve protocols, reports, and other technical documents required for the qualification and transfer of analytical methods.
• Conduct laboratory investigations, handle deviations, manage out-of-specification (OOS) results, and implement change controls and corrective and preventive actions (CAPAs).
• Support equipment qualification, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Create, maintain, and revise Standard Operating Procedures (SOPs), methods, and associated documents.
• Support all operations of the QC labs, including ordering supplies and maintaining laboratory equipment and spaces.
• Contribute to client audit and inspection readiness plans and interact with regulatory agencies during inspections on analytical-related matters.
• Participate in daily and weekly operational meetings.

Essential Skills

• Bachelor's degree in Chemistry, Biochemistry, or related field.
• 3-5 years of Quality Control experience in the GMP biopharmaceutical or biotechnology industry.
• Laboratory experience with HPLC or UPLC chromatography systems and capillary electrophoresis techniques.
• Familiarity with chromatography data systems.
• Knowledge of GMP regulations and experience with regulatory compliance inspections.

Additional Skills & Qualifications

• Ability to adapt and work in a fast-paced environment.
• Capability to manage multiple projects and priorities simultaneously.
• Excellent oral, written, and interpersonal communication skills.
• Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).

Work Environment

The work environment includes operating in GMP facilities located in Seattle and Redmond, WA. The role requires interaction with sophisticated laboratory equipment and technologies such as HPLC, UPLC, and capillary electrophoresis systems. The position involves working in a dynamic and fast-paced environment, requiring flexibility and the ability to manage multiple tasks. The dress code is business casual, suitable for laboratory settings.