A Quality Control Analyst, in the biotech and medical device industries, works in laboratories performing biological, microbiological, and chemical tests on products and materials. Responsible for calibrating equipment, inspecting products, processing and testing materials, and reporting results. May work in other production environments to monitor and improve quality and efficiency in production systems and products.
Wilsonville, OR Position Summary 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 onsite at our Wilsonville, OR site, Monday-Friday 8:00 - 5:30 pm PT. Key Responsibilities Support the review and release of basic products against established QC metrics under the direction of senior QC staff. 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. Perform raw material incoming inspections based on established processes and specifications. 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). Maintain QC records and instrument logs following Good Documentation Practices (GDP). Support investigations of out-of-specification (OOS) and out-of-trend (OOT) results by gathering raw data and documenting findings. Assist in compiling routine QC reports and metrics. Support continuous improvement initiatives in the QC laboratory under guidance. Maintain QC instruments per calibration and preventive maintenance schedules. Prepare reagents, buffers, standards, and assay controls per SOP, including labeling, expiry tracking, and inventory records. Perform environmental monitoring and water sampling as applicable to the site. Promptly identify and escalate atypical, out-of-specification, and out-of-trend results to senior QC staff or supervision. Maintain data integrity in accordance with ALCOA+ principles and 21 CFR Part 11 requirements for electronic records, signatures, and audit trails. Operate in full compliance with applicable regulatory requirements, ISO 13485:2016, and internal SOPs. Required Qualifications BS in Biochemistry, Chemistry, Molecular Biology or related field. 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. Knowledge of molecular biology techniques such as PCR, Cloning & Sequencing. Knowledge of analytical techniques such as spectroscopy, gel electrophoresis, etc. 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. Excellent verbal and written communication skills Basic laboratory skills (pipetting, sample handling, instrument operation). Working knowledge of Good Manufacturing Practices and good documentation practices (GDP). Ability to work on-site to inspect products and materials and release lots. Competencies Works under direct supervision; follows established written procedures. Detail-oriented and reliable. Clear written and verbal communicator within the QC team. Thrives in a fast-paced, team-oriented, and collaborative environment. Working Conditions & Physical Requirements On-site role performed in laboratory, cleanroom, and manufacturing environments requiring gowning and personal protective equipment. Frequent standing, walking, and repetitive pipetting; ability to lift up to 25 lbs with or without reasonable accommodation. Release testing timelines may require shift, weekend, holiday, or on-call rotation coverage.
