BASi Northwest Laboratories [www.basinc.com] has an opportunity for a Quality Assurance Manager. The position is based in our R&D facility in McMinnville, Oregon. This division is involved in bioanalytical chemistry using LC-MS/MS following US FDA regulations. 

The Quality Assurance manager would have the following responsibilities:

• management of the quality programs
• compliance with the appropriate federal regulations, such as, US FDA GLPs and GCPs and the Guidance on the Validation of Bioanalytical Methods
• management of regulatory inspections and sponsor audits
• supervision of 3-6 direct reports

We are looking for a candidate with the following qualification:

·       supervisory experience

·       FDA background, particularly in GLP regulations

·       a B.S./B.A. in chemistry or closely related science

·       at least 5 years of direct quality assurance experience in the pharmaceutical industry.

·       experience writing and reviewing SOPs

·       self-motivated,  excellent oral, written, and computer communication skills, above average attention-to-detail focus

·       an advanced degree in business or science and experience designing quality systems is desirable

Resumes should be sent to lpayne@basinc.com or faxed to HR Manager at 503-472-4863