Location: 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.
