Work-Related Experience?
Megan Matthews 11849
Joined 01/30/2020 - 1 Posts

I am looking to take my first ASQ certification exam.  I am currently in a quality systems role (a little less than 2 years).  I had two questions that I would appreciate insight into.

1) I had 3.5 years of experience in Quality Control, were I did work with deviations, change controls, and CAPAs.  Would this could as work experience for either auditing certifications?

2)As someone looking to get into auditing of CMOs and suppliers in the pharmaceutical industry, would you recommend the Biomedical Auditor Certification or the Certified Quality Auditor?

Any insights would be very appreciated as someone just getting into ASQ.

Thank you,
2 Replies
Jeremiah Genest 217
Joined 04/20/2018 - 214 Posts
To answer your second question first, the BioMedical Auditor has several areas that are very medical device focused, which will be similar but not quite what you know as a pharmaceutical quality systems individual, and that dissonance might be jarring. Looking at the new BoK (live in July of this year) section 3 focuses on regulations so it is very 820 and ISO 13485 focused. Section 4 on techncial design is remarkably different in several key areas. Those two big differences would probably steer me to the CQA.

As far as the first, work experience, the requirements in the CQA is 8 years in at least one area in the BoK. You have 5.5. Not sure if you qualify as decision making yet (depends on your organization). The Biomedical Auditor only requires 5 years.

Trish Borzon 9
Joined 12/05/2017 - 494 Posts
Hi Megan - See what you qualify for by using our Certification Pathways tool

good luck!