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

Evotec•Redmond, WA

1d•Onsite

About The Position

We’re looking for a passionate and curious Senior QA Specialist 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 Senior QA Specialist 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. 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.

Requirements

Bachelor’s 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

Responsibilities

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 documentation both 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.

Benefits

Growth Opportunities: We’re a company that believes in continuous learning and development. Whether it’s professional courses, mentorship, or new projects, we’ll help you grow.
Flexible Work Environment: We offer flexible work options to help you balance your professional and personal life.
Inclusive Culture: We’re committed to building a diverse and inclusive environment where everyone’s voice is valued, and curiosity is encouraged.
Innovative Projects: You’ll 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 don’t just talk about thinking outside the box—we throw the box away. If you’ve got ideas, we want to hear them.
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