Evotec · 1 day ago
Quality Assurance Associate
Seattle, WA
Full-time
Hybrid
Entry Level
$65K/yr - $90K/yr
1+ years expJust-Evotec is a forward-thinking company focused on innovation and success. They are seeking a passionate QA Associate to execute day-to-day QA responsibilities for GMP manufacturing and ensure compliance with regulatory standards.
BiotechnologyHealth CarePharmaceuticalTherapeutics
Responsibilities
Review executed Manufacturing Batch Records
Participate in compliance walkthrough of the Manufacturing floor and other assigned areas
Partner with Manufacturing to ensure compliance in Manufacturing operations
Review and approve Master Batch Records and other supporting documents
Execute process performance and product quality monitoring programs
Alert senior management of potential deviations or compliance risks
Initiate and review all quality events of eQMS (Deviations, Change Control, CAPA, Risk Assessment, Management Review, Complaint Investigation, Product Quality Review etc.) to assure compliance with regulatory and Just-Evotec Global Quality Management Systems (G-QMS) requirements
Provide input on communication as to the status of deliverables to customers, management, and stakeholders
Assist with developing training regarding QMS process or system changes
Support QA QMS in internal and external client audits and regulatory inspections (including but not limited to SME for QMS processes and individual records)
Monitor effectiveness for QMS through trending, analysis, and metrics; report to top management and G-QMS on the performance of the KPIs and identify opportunities for continuous improvement
Lifecycle management of the stability program for clinical and commercial products
Act as the QA representative on cross-functional product teams to integrate stability activities with project milestones
Support the design of stability protocols to ensure that they are aligned with program strategy and regulatory requirements
Ensure that stability studies are executed according to protocol
Review, verification, disposition, and archival of stability study data for assigned programs
Escalate unexpected data trends, OOS events, and risks appropriately, and drive/support resolution
Interpretate stability results to support expiry, trending, and conditions of products
Support product stability related content in regulatory submission, including responses to questions and post-marketing
Qualification
Required
Bachelor's Degree biological sciences, chemistry, biochemistry, engineering, or related life science field and 1 year of relevant quality experience OR Associate's degree and 3 years of relevant quality experience OR High school diploma / GED and 6 years of relevant quality experience
Strong attention to detail
Ability to collaborate and communicate cross-functionally
Benefits
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
Paid holiday
Wellness and transportation benefits
Company
Evotec
Evotec is a pharmaceutical and life science company that provides drug discovery and gene therapy solutions.
5001-10000 employees
H1B Sponsorship
Evotec has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2023 (2)
2022 (2)
2021 (3)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$746.74MKey Investors
Bill & Melinda Gates FoundationKorea Advanced Institute of Science and TechnologyOpen Philanthropy
2025-05-07Grant· $2.5M
2025-01-22Grant
2023-12-19Grant· $2.5M
Leadership Team
Christian Wojczewski
CEO
Claudia Karnbach
EVP, Global Head of Partnerships and Alliances
Recent News
2026-01-07
Company data provided by crunchbase