Sr. QA Specialist/ GMP Auditor Jobs Seattle, WA
Job Duties:
- Act as SME for the overall GMP auditor program manage the overall GMP audit program
- Maintain detailed understanding of current U.S. and international regulatory requirements
- Act as lead auditor for both internal and external cGMP audits
- Prepare audit reports based on findings
- Follow up on corrective actions related to audit findings, nonconforming product, or overall supplier performance to ensure effective
- Act as lead for the Quality System (i.e. deviation, CAPA, change control, product complaints, etc.)
- Provide QA Compliance support
- Evaluate employee training for SOPs on auditing practices
Job Requirements:
-Must have experience performing/leading audits
-Must be able to assess and qualify new bulk drug substance CMOs (both clinical and commercial) based on facilities and system evaluations
- BA/BS in science related field
- 6-10 years experience in a QA/QC function in the pharmaceutical/biotech industry
- Must have bulk drug substance/ biologics experience
- Exeprience acting as a lead auditor for cGMP audits
- ASQ Certified Quality Auditor - preferred
- Must be able to travel 25% - 50% - domestic and international
- Excellent communication skills required
**Relocation is not an option and position is based in Seattle, WA**