QC Scientist, Site Based, Redmond, WA

Cyprotex•Redmond, WA

18h•Onsite

About The Position

At Just Evotec Biologics, we believe that curiosity is the spark that drives innovation and success. As a forward-thinking team, we thrive on challenging the status quo, learning from each other, and pushing the boundaries of what’s possible. We're on a mission to create a place where curiosity isn't just encouraged—it’s celebrated. Are you someone who asks questions, seeks answers, and isn't afraid to go deeper? #BeCureious with us and see where your curiosity can take you! The Role: / your challenge, …in our journey We’re looking for a passionate and curious QC Scientist to join our team. If you’re excited by new challenges, solving complex problems, and learning every step of the way, you might just be the perfect fit. In this role, you’ll have the opportunity to drive impactful projects, collaborate with bright minds, and explore uncharted territories. As a QC Scientist at Just Evotec Biologics, you'll have the freedom to ask the hard questions, think outside the box, and find creative solutions that push us forward. It’s a role where your curiosity will fuel both your personal growth and the success of the team. Position This role provides the QC analysis of raw materials, in-process, drug substance and drug product samples in support of our GMP manufacturing operations at the Redmond, WA GMP facilities. These efforts support GMP manufacturing activities for biotherapeutic products.

Requirements

BS in Biochemistry, molecular / cellular biology or chemistry or related field and 3 plus years of Quality Control experience in GMP biopharmaceutical or biotechnology industry.
Knowledge of GMP regulations and experience with regulatory compliance inspections.
Hands on experience in the execution of potency and impurity methods (cell-based assays, immunoassays, and qPCR).
Laboratory experience with mammalian cell culture and cell banking.
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).

Responsibilities

Perform routine/non-routine QC testing using by techniques such as cell-based assays, ELISA, and qPCR.
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).
Create, maintain, and revise SOPs, methods and associated documents.
Support all operations of the QC labs including the ordering supplies and maintaining laboratory equipment and lab spaces.
Support client audit/inspection readiness plans and interact with regulatory agencies during inspections on analytical related matters.
Participate in daily and weekly operation meetings.