Quality Assurance Associate I
Are you a problem-solver? A collaborator? Ready to tackle the world of infectious diseases? InBios is looking for people who value a sense of community, cooperation, and camaraderie with a shared vision of delivering impactful solutions to those affected by infectious diseases. At InBios, your ideas are valued, your voice is heard, your accomplishments are celebrated.
InBios International Inc. specializes in the design, development, and manufacture of diagnostic assays for emerging infectious diseases and biothreats. Founded in 1996 in Seattle, WA, InBios is dedicated to delivering superior quality products that are accurate, easy to use and cost effective. We have a portfolio of more than 25 diagnostic products, as well as an extensive catalog of life science reagents. For more information, visit www.inbios.com.
Our primary location is in the South Lake Union neighborhood in a state-of-the-art biotech facility, and our secondary location is in the SODO neighborhood with newly remodeled lab and office space in an historic building next to Lumen Field. InBios offers competitive wages and a rich benefit package that includes medical, dental and vision insurance, 401(k), and performance-based rewards. InBios is committed to work/life balance and provides paid vacation and sick time, including a weeklong, paid shutdown in December.
We are seeking a mindful and diligent individual with a warm and welcoming attitude who has excellent organizational and communication skills and a keen eye for detail. If you enjoy hands-on optimization and troubleshooting of equipment and processes, analytical work, leading and collaborating on projects, and being part of a reliable and dedicated Quality Assurance team, then we encourage you to apply for this position.
Experience and knowledge needed to be successful in this position
- BS or BA in engineering with 1+ years experience working in a FDA regulated industry or MS with 0+ years experience.
- Experience with and working knowledge of cGMP, ISO 13485:2016, and GLP quality systems, policies and regulations/guidelines.
- Prior experience training staff on cGMP and equipment operations.
- Demonstrated knowledge of quality engineering medical device regulations, supplier quality control, design control and risk management.
- Ability to lead and coordinate cross-functional projects.
- Experience leading CAPA and Deviation Management to closure.
- Exceptional analytical and problem-solving skills with the proven ability to think strategically.
- Strong written and verbal communication skills.
- Excellent knowledge of MS Word and Excel. Experience with databases and electronic documentation systems is a plus.
- Thesis-based MS Degree.
- Prior experience validating ELISA, lateral flow, real-time PCR assays and/or production equipment (FAT/SAT/IQ/OQ/PQ).
- Proficiency in statistical analysis.
Job duties include
- Under the guidance of senior QA staff, execute FAT/SAT and IQ/OQ/PQ validations for manufacturing equipment.
- Lead staff trainings to ensure continued adherence to cGMP.
- Lead review of quality records and set up DMRs and DHRs.
- Coordinate and conduct internal audits and supplier audits.
- Oversee, coordinate and review tracking of Deviations, Change Controls, CAPAs.
- Conduct root cause failure analyses and corrective actions.
- Review and approve batch records, device history records, deviations, change controls, corrective and preventive actions (CAPA) and specifications.
- Work with R&D and manufacturing to ensure effective design transfer.
- Provide input to cross-functional teams to ensure Design Controls are understood and applied.
Work environment information
Position responsibilities include work in a Biosafety Level 2 lab (BSL-2) and a humidity-controlled environment.
Wage commensurate with industry standard and experience. Benefits include medical, dental, and 401(k)