QC Senior Scientist - Analytical

Just is seeking a highly motivated individual who desires a significant opportunity to improve worldwide access to biotherapeutics. The QC Senior Scientist will provide the QC analysis of raw materials, in-process, drug substance and drug product samples in support of our GMP manufacturing operations at the Seattle and Redmond, WA GMP facilities. These efforts support GMP manufacturing activities for biotherapeutic products. 

Responsibilities 

• Perform routine/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, deviations, OOS, change controls and CAPAs. 

• Support equipment qualification (IQ, OQ, PQ). 

• Support QC management in the timely review of data. 

• Develop, revise, and review SOPs, methods and associated documents. 

• Support all operations of the QC labs including the ordering supplies, maintaining laboratory equipment and lab spaces, , and logbook reviews. 

• Support client audit/inspection readiness plans and interact with regulatory agencies during inspections on analytical related matters. 

• Participate in daily and weekly operation meetings. 

• Provide on-the-floor mentorship, training and technical leadership for less experienced staff as an individual contributor. 

Requirements 

• BS in Chemistry, Biochemistry, or related field with a minimum of five years of Quality Control experience in GMP biopharmaceutical or biotechnology industry. 

• Extensive laboratory experience with either HPLC / UPLC chromatography systems or capillary electrophoresis techniques. 

• Experience with capillary electrophoresis or chromatography data systems. 

• Knowledge of GMP regulations and experience with regulatory compliance inspections. 

• Ability to adapt, work in a fast-paced environment, manage multiple projects and priorities at the same time. 

• Excellent oral/written and interpersonal communication skills; and a knowledge of Microsoft Office Suite (Excel, Word, PowerPoint). 

• Ability to work independently and with others to accomplish goals and priorities. 

• Must possess effective time management skills, demonstrate initiative, resourcefulness and flexibility to work independently and as part of a team. 

This job description is intended to describe the general content of the job, and to identify the essential functions of and requirements for the performance of this job.  It is not to be construed as an exhaustive statement of duties, responsibilities, or requ