QC Associate - Temp

<p><strong>Location: Wilsonville, OR</strong></p> <p><strong>Position Summary</strong></p> <p>The QC Associate I performs routine QC testing and product release activities under direct supervision. The role operates analytical instruments, executes validated test methods, and supports investigations of out-of-specification and out-of-trend results in compliance with ISO 13485:2016. This position is <strong>onsite </strong>at our <strong>Wilsonville, OR</strong> site, <strong>Monday-Friday 8:00 - 5:30 pm PT. </strong></p> <p><strong>Key Responsibilities</strong></p> <ul> <li>Support the review and release of basic products against established QC metrics under the direction of senior QC staff.</li> <li>Perform routine QC release testing and data review using established acceptance criteria and validated test methods; prepare disposition recommendations for verification and approval by a QC Associate II or above.</li> <li>Perform raw material incoming inspections based on established processes and specifications.</li> <li>Execute analytical testing per SOPs (e.g., quantitative measurements via NanoDrop/Qubit, fragment analysis via TapeStation/Fragment Analyzer, qPCR, and basic NGS QC tasks, as applicable).</li> <li>Maintain QC records and instrument logs following Good Documentation Practices (GDP).</li> <li>Support investigations of out-of-specification (OOS) and out-of-trend (OOT) results by gathering raw data and documenting findings.</li> <li>Assist in compiling routine QC reports and metrics.</li> <li>Support continuous improvement initiatives in the QC laboratory under guidance.</li> <li>Maintain QC instruments per calibration and preventive maintenance schedules.</li> <li>Prepare reagents, buffers, standards, and assay controls per SOP, including labeling, expiry tracking, and inventory records.</li> <li>Perform environmental monitoring and water sampling as applicable to the site.</li> <li>Promptly identify and escalate atypical, out-of-specification, and out-of-trend results to senior QC staff or supervision.</li> <li>Maintain data integrity in accordance with ALCOA+ principles and 21 CFR Part 11 requirements for electronic records, signatures, and audit trails.</li> <li>Operate in full compliance with applicable regulatory requirements, ISO 13485:2016, and internal SOPs.</li> </ul> <p><strong>Required Qualifications</strong></p> <ul> <li>BS in Biochemistry, Chemistry, Molecular Biology or related field.</li> <li>0-2 years of industrial experience in Operations/QC; internship, co-op, or relevant academic laboratory experience will be considered in lieu of industry experience. Foundational knowledge of Quality Control and Quality Assurance principles.</li> <li>Knowledge of molecular biology techniques such as PCR, Cloning &amp; Sequencing. </li> <li>Knowledge of analytical techniques such as spectroscopy, gel electrophoresis, etc.</li> <li>Basic familiarity with laboratory data systems (e.g., LIMS); hands-on experience with automated liquid-handling or robotic systems is preferred, not required, and training is provided.</li> <li>Excellent verbal and written communication skills</li> <li>Basic laboratory skills (pipetting, sample handling, instrument operation).</li> <li>Working knowledge of Good Manufacturing Practices and good documentation practices (GDP).</li> <li>Ability to work on-site to inspect products and materials and release lots.</li> </ul> <p><strong>Competencies</strong></p> <ul> <li>Works under direct supervision; follows established written procedures.</li> <li>Detail-oriented and reliable.</li> <li>Clear written and verbal communicator within the QC team.</li> <li>Thrives in a fast-paced, team-oriented, and collaborative environment.</li> </ul> <p><strong>Working Conditions &amp; Physical Requirements</strong></p> <ul> <li>On-site role performed in laboratory, cleanroom, and manufacturing environments requiring gowning and personal protective equipment.</li> <li>Frequent standing, walking, and repetitive pipetting; ability to lift up to 25 lbs with or without reasonable accommodation.</li> <li>Release testing timelines may require shift, weekend, holiday, or on-call rotation coverage.</li> </ul>