Sr. Quality Manager (Immunoassay Production) - O'Fallon, MO | Biospace
Get Our FREE Industry eNewsletter

Sr. Quality Manager (Immunoassay Production)

Adarza Biosystems, Inc

Location:
O'Fallon, MO
Posted Date:
11/10/2016
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Manager, Medical Device, Quality,

Job Description


Adarza BioSystems, Inc. is a venture capital backed biotechnology company developing label-free protein microarray assays based on the Company’s proprietary Arrayed Imaging Reflectometry (AIR™) platform. Adarza is seeking a Quality Manager to implement our QMS and lead the ISO 9001:2015 certification process. Reporting to the Head of Missouri Operations, this individual will have an opportunity to develop and grow with a dynamic, emerging company in the greater St. Louis, MO area.

The position requires proven expertise in creating and maintaining a Quality Management system, starting with the Quality Policy and then translating this to a compete QMS system with appropriate document control and training. The identification of a suitable electronic document
system will be an early job responsibility.

In addition, the candidate must be able to show strong understanding of the ISO implementation process, as their secondary role will be to lead team efforts toward ISO accreditation.


Requirements


Qualifications with Track Record of Achievement:
• Past quality experience in a relevant industry.
• Biotech, Medical Device, Medical Research, etc is desirable.
• Past industry experience in Quality Management, Control, and Assurance.
• Experience with implementing and maintaining ISO requirements and GMP guidelines.
• Demonstrable self-motivation and a solid work ethic.
• Attention to detail combined with strong prioritizing and multi-tasking skills to work within deadlines.
• Strong analytical and problem solving skills.
• Proven ability to effectively collaborate with others, initiate actions, adapt to change, and accept challenging assignments.
• Demonstrated ability to effectively and clearly communicate concepts, ideas and knowledge.
• Excellent oral and written communication skills. Clear/Concise documentation and during project execution.