QA Associate, OTF Support (temporary)

<p><strong>This is a six-month position on-site in Seattle, WA.</strong></p> <p>Join Lumen as a QA Associate for OTF Support in this temporary position (schedule below). In this role, you’ll help maintain our cGxP-compliant quality management system by supporting cGLP/cGMP/cGCP activities, conducting facility walkthroughs, and ensuring production records and documentation are complete, accurate, and audit-ready. Your work will directly support Lumen’s commitment to operational excellence and regulatory compliance across our manufacturing operations.</p> <p>You’ll perform tasks including controlled document scanning and archival, batch record and process documentation review, issuance of process documentation for scheduled manufacturing runs, and on-the-floor QA support for production teams. You’ll help monitor compliance with 21 CFR part 210/211 standards through routine facility and operations walkthroughs, maintain high-quality records of activities, and collaborate closely with QA leadership to support investigations, metrics reporting, and continuous improvement of our quality systems.</p> <p><strong>Duties & Responsibilities:</strong></p> <p>This position requires working under the 21 CFR part 210 /211 standard pharmaceutical cGXP quality system processes.</p> <ul> <li>Perform document scanning and archival of controlled records.</li> <li>Maintain accurate records of activities.</li> <li>Perform on-the-floor support for manufacturing operations. </li> <li>Perform issuance of process documentation for scheduled manufacturing operations. </li> <li>Perform review of Batch records and related process documentation.</li> <li>Conduct facility and operations walkthroughs to ensure compliance with the Company’s 21 CFR part 210 /211 standard pharmaceutical cGxP quality processes.</li> <li>Support the QA Manager and QA Specialist in all QA related tasks.</li> <li>May assist in the preparation of metrics reports.</li> <li>May assist with the investigation and triage of deviations, CAPAs, or other quality events.</li> </ul> <p><strong>Qualifications & Requirements:</strong></p> <ul> <li><u>Education and Experience:</u> <ul> <li>Minimum 1 year of work experience in a regulated (cGXP) organization or a minimum of an associate's degree in a relevant scientific field</li> <li>Knowledge of relevant cGMP, ISO 9001, and ICH requirements for document control and quality records</li> <li>High level of proficiency in Microsoft Word, Excel, and SharePoint.</li> </ul> </li> <li><u>Skills and Attributes:</u> <ul> <li>Well-organized and detail-oriented with strong technical skills, excellent written and verbal communication skills, and proven ability to multitask</li> <li>Strong interpersonal skills and the ability to effectively collaborate with others in a dynamic team environment</li> <li>Capable of supporting multiple projects simultaneously in a deadline-driven environment</li> <li>Adaptability, flexibility, independence, and resourcefulness to thrive in a fast-paced, small-company environment</li> <li>High integrity and ethics</li> <li>Commitment to quality and timely delivery of results</li> </ul> </li> </ul> <p><strong>Physical Requirements:</strong></p> <ul> <li><span style="text-decoration: underline;">Schedule:</span> 10:00 AM-6:00 PM, Monday-Friday </li> <li>Ability to sit/stand for extended periods of time (2 or more hours)</li> <li>Occasionally lift or carry up to 23 kg</li> </ul> <p><strong>Benefits at Lumen Bioscience:</strong></p> <ul> <li>Free onsite parking</li> </ul> <p>At Lumen Bioscience, we foster a workplace built on collaboration, innovation, and professional growth. This role offers a significant opportunity to contribute directly to cutting-edge biotechnology and the advancement of global health solutions.</p> <p><strong>Join us to shape innovative solutions and drive operational excellence.</strong></p><div class="content-pay-transparency"><div class="pay-input"><div class="title">Compensation Range</div><div class="pay-range"><span>$27</span><span class="divider">—</span><span>$30 USD</span></div></div></div>