Lab QA Associate
Nexelis is an immunology-centric CRO specialized in clinical assay development in single and multiplex formats and sample analysis for low-, mid- and large-scale clinical testing. Our versatile team of scientists and technology platforms have been instrumental in the development, qualification and validation of assays supporting FDA filings of over 100 new molecular entities, including blockbuster biologics such as vaccines and complex large molecules.
Our Seattle office focuses on Bioanalytical Services (PK, Immunogenicity ADA Assays, & Fit-for-Purpose Biomarkers), in addition to offering an extensive Biomarker Menu.
We are seeking a QA Associate to join our fast-growing Seattle office, where the opportunity for career advancement is tremendous!
If you are interested in working in a dynamic biotechnology environment that is challenging, rewarding and a source of personal pride and growth, we’re interested in hearing from you! Nexelis is located in Seattle, surrounded by mountains, forests and waterways of the Pacific Northwest.
- Maintain document control systems and implement the appropriate quality-related policies and procedures required for regulatory compliance.
- Review policies and procedures for regulatory compliance and consistency, as well as policies for business and technical practices, and convey those throughout the company.
- Serve as a primary resource for maintaining safety policies and procedures.
- Undertake and assist with a variety of audits, such as audits for facilities, process, third-party and study-specific audits.
- Participate in root-cause analysis and other problem solving/investigation activities to ensure that effective corrective/preventive actions are implemented, and processes are improved
- Assist management in developing and providing applicable safety, regulatory and quality-related trainings.
- Maintain records for in-house training and continuing education for laboratory and laboratory support personnel and assists with identifying training needs and continuous improvement of training activities.
- Maintain internal and external document archives.
- Provide support for document archiving and retrieval.
- Participate in collecting data to support mandated reporting and assist with performance analysis.
- Assist with certification and accreditation processes.
Experience and Qualifications
- Working knowledge of quality assurance audit procedures.
- Understanding of documentation requirements for regulatory compliance.
- Well-developed communication skills to convey technical concepts and conduct trainings.
- Knowledge of document control techniques is highly desirable.
- Associate’s or bachelor’s degree in medical technology or science, plus a minimum of 2-3 years of clinical lab and/or quality assurance experience.