Quality Assurance Associate II

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.

ABOUT INBIOS

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 dynamic neighborhood of South Lake Union 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. We also have a stand-alone storage and office facility that is a short walk from our primary location. 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.

ABOUT YOU

We are seeking a mindful and diligent individual with experience in all aspects of quality assurance as it pertains to in-vitro diagnostic products.  A solid understanding of immunoassays is required as well as molecular assays and associated FDA regulations.  If you enjoy leading and collaborating on projects, performing a variety of tasks, and working with the FDA and other regulatory bodies, 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 with 3+ years’ experience or MS with 1+ years’ experience working in a IVD or medical device industry.
• Experience with and good working knowledge of cGMP (21 CFR 820), ISO 13485:2016, and GLP quality systems, policies, and regulations/guidelines.
• Demonstrated knowledge of supplier quality management, design control for Class II products and risk management throughout the product’s life cycle.
• Experience utilizing root cause analysis tools to perform thorough NCMR and CAPA investigations.
• Experience training staff on cGMP.
• Ability to conduct internal and supplier audits.
• Expertise in assessing and monitoring process controls in an automated manufacturing environment.
• Exceptional analytical, statistical, 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.

Preferred qualifications:

• Thesis-based MS Degree in engineering or life sciences.
• Familiar with the principles of ELISA, rapid immunoassay, and molecular assay production.
• ASQ certifications in ISO 13485.
• Proficiency in statistical analysis.

Job duties include:

• Manage and review tracking of Deviations, Change Controls, CAPAs.
• Prepare, maintain, and analyze metrics related to the quality systems.
• Conduct root cause failure analyses and corrective actions.
• Identify product failure modes and provide possible solutions through product quality and process improvements.
• Lead staff trainings to ensure continued adherence to cGMP.
• Review and approve batch records, device history records, deviations, change controls, corrective and preventive actions (CAPA) and specifications.
• Author DMRs.
• Coordinate and conduct internal audits and supplier audits.
• Work with R&D and manufacturing to ensure effective design transfer.
• Conduct process evaluations and validations utilizing tools such as SPC, DOE and capability studies.
• Participate/lead risk management activities including FMEAs.

Work environment information:

• This is an on-site office position which requires an ability to sit and work at a computer for long periods during the workday.
• This position includes some work that takes place in a BSL-2 laboratory and a humidity-controlled room.

Wage/Benefits information:

Salary Range (annually): $75,000.00 - $120,000.00

Employees (and their families) are able to enroll in medical, dental, vision, and voluntary life insurance.  Employees are covered by basic life insurance and long-term disability insurance.  Employees are able to enroll in our company's 401k and/or Roth IRA retirement savings plans and Flexible Savings Account (FSA). Employees accrue 2-weeks of paid vacation per year and a total of eleven paid holidays throughout the year, which includes the holiday observance of winter break at year end (the workdays between Christmas Day and New Year's Day).