QA Senior Specialist, Site Based, Redmond, WA

Evotec•Redmond, WA

17h•Onsite

About The Position

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

Quality Control working experience – preferably in documents revision and approval level.
OOS and investigation experience
Experience in helping to build and maintain a Quality infrastructure in a fast-paced growing company.
Comprehensive understanding of biologics regulatory requirements, risk management principles, and science-based decision making.
Experience in laboratory testing such as: SEC UHPLC, Potency and Residual Protein (ELISA), Osmolality, Solo VPE, Capillary Electrophoresis (SDS/rCE-SDS), Assay (icIEF), Experience in release testing, stability testing, equipment qualification, and method qualification
Experience in tools, concepts, and methodologies of QA
Strong computer skills including Microsoft Office and eQMS databases, including LIMS, CMMS, MES
Key competencies in verbal and written communication; attention to detail; data collection, management, and analysis; judgement and decision making; and building teams.
Bachelor’s degree in biological or engineering science
Minimum of 5 years relevant experience in a Supplier Quality environment, biopharmaceutical/Pharmaceutical cGMP manufacturing or similar environment.
Ability to collaborate and communicate cross-functionally.
Proven attention to detail.

Responsibilities

Conduct supplier and material onboarding activities in accordance with approved procedures
Conduct supplier onboarding audits and routine performance monitoring audits.
Conduct internal GMP Supplier Quality events (e.g., complaints, deviations, CAPAs) with escalation of critical issues affecting patient safety, product quality, or supply.
Assess supplier change notifications and initiate/process any follow-up actions necessary to determine impact and ensure compliance.
Negotiate and maintain quality agreements with service and material suppliers.
Conduct routine qualification of service and material suppliers.
Create, update and obsolete material specifications as needed.
Maintain supplier and material onboarding and performance documentation file.
Assess change controls for impact to supplier quality management.
Participate in raw material risk assessments.
Conduct investigations of supplier-related quality issues and root causes.
Other tasks as determined by management.
Travel to JEB sites as required.