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SalaryAre 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 proven experience working in positions that require critical thinking, problem solving, and sound judgement. This individual will have a warm and welcoming attitude, excellent organizational and communication skills, and a keen eye for detail. If you enjoy helping others to understand and apply GMP principles, finding pragmatic solutions to compliance challenges in a growing company, 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:
- Bachelor's degree (BS) in chemical, mechanical or bioengineering, or related discipline.
- BS with 3+ years relevant experience or MS with 1+ years relevant experience.
- Experience working in a GMP, FDA, ISO and/or USDA regulated environment.
- Experience working with automated manufacturing equipment preferred.
Job duties include:
- Analyze manufacturing processes, identify methods of improving efficiency (while maintaining cGMP), and work with relevant departments to implement changes.
- Identify product failure modes and provide possible solutions through product quality and process improvements.
- Collaborate with Manufacturing Engineers to troubleshoot equipment related production issues and implement necessary improvements.
- Assist with process development efforts during product transition from R&D to Manufacturing.
- Review, author, and/or approve batch records, device history records, deviations, nonconformances, and corrective and preventive actions (CAPA).
- Conduct root cause failure analyses and corrective actions.
- Prepare, maintain, and analyze metrics related to the quality systems.
- Design and conduct process and equipment evaluations and validations. Perform validation impact assessments.
- Contribute to the qualification, validation, calibration, and maintenance of facilities, utilities, laboratory and manufacturing equipment.
- Coordinate and conduct internal audits and assist Quality Assurance Associates, as needed.
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 - $110,000.00
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).
