Sr. Specialist, QA, Site Based, Redmond, WA

Job Title: Senior QA Specialist - Document Control

Location: Redmond WA

Shift: Monday to Friday Days.

About Us: this is who we are

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 whats possible. Were on a mission to create a place where curiosity isnt just encouragedits celebrated.

Are you someone who asks questions seeks answers and isnt afraid to go deeper #BeCureious with us and see where your curiosity can take you!

The Role: / your challenge in our journey

Were looking for a passionate and curious Senior QA Specialist to join our team. If youre excited by new challenges solving complex problems and learning every step of the way you might just be the perfect this role youll have the opportunity to drive impactful projects collaborate with bright minds and explore uncharted territories.

As a Senior QA Specialist at Just Evotec Biologics youll have the freedom to ask the hard questions think outside the box and find creative solutions that push us forward. Its a role where your curiosity will fuel both your personal growth and the success of the team.

The Senior QA Specialist works cross-functionally to ensure compliance in operations to cGMP expectations and company SOPs. The Sr. Specialist is responsible for increasingly complex records and tasks as well as training of junior personnel. The responsibilities of the employee is based on the assigned QA organization as outlined below.

What Youll Do:

• Issue production batch records labels and other documents to support manufacturing operations as scheduled. This includes delegation of these tasks among QA Associates/Specialists.

• Issue documents and labels to support quality control operations as needed. This includes delegation of these tasks among QA Associates/Specialists.

• Create and issue logbooks.

• Approve document control related documents in the electronic document management system.

• Serve as primary point of contact and guidance for site functional areas regarding documents and label controls.

• Responsible for reconciliation and archival of controlled documentation.

• Support the development and deployment of document control tools processes or services. This includes updates through change controls or via CAPAs.

• Responsible for the management of document control room and archival of documentationboth onsite and offsite.

• Support internal and external client audits and regulatory inspections including but not limited to SME for document control and the archive room and document retrieval.

• Complete investigation write ups for document control related deviations in a timely manner.

• Perform routine and ad hoc labeling and issuance metric reporting and analysis for the local site data.

• Occasional on-call document or label support for off-hours operations.

Who You Are:

• Bachelors degree in biological or engineering science

• Minimum of 5 years relevant experience in a biopharmaceutical/Pharmaceutical cGMP manufacturing or similar environment.

• Ability to collaborate and communicate cross-functionally.

• Proven attention to detail

Why Join Us:

• Growth Opportunities: Were a company that believes in continuous learning and development. Whether its professional courses mentorship or new projects well help you grow.

• Flexible Work Environment: We offer flexible work options to help you balance your professional and personal life. This role is site based.

• Inclusive Culture: Were committed to building a diverse and inclusive environment where everyones voice is valued and curiosity is encouraged.

• Innovative Projects: Youll have the chance to work on groundbreaking initiatives and cutting-edge technology in an atmosphere where your curiosity is the key to success.

• A Place for Big Ideas: We dont just talk about thinking outside the boxwe throw the box away. If youve got ideas we want to hear them.

Are You Still Curious

If youve read this far then chances are youve got a curious mindjust like us. So what are you waiting for Take the leap and apply today. We cant wait to see where your curiosity leads youand how it will shape the future of Just Evotec Biologics.

Let your curiosity guide your career#BeCurious and explore the endless possibilities at Just Evotec Biologics!

The base pay range for this position at commencement of employment is expected to be $92400 to $126500; Base salary offered may vary depending on the individuals skills experience and competitive market value. Additional total rewards include discretionary annual bonus comprehensive benefits to include Medical Dental and Vision short-term and long-term disability company paid basic life insurance 401k company match flexible work generous paid time off and paid holiday wellness and transportation benefits.

Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race gender age disability genetic information gender expression gender identity national origin religion sexual orientation or veteran status.