Senior Quality Auditor/GMP Auditor

We are looking for a Senior Quality Auditor to join our network of qualified associates!

You will be responsible for performing Quality System and GMP compliance Audits of Suppliers to the Medical Device, Pharmaceutical, or Cosmetics manufacturing industries. The overall goal of SQA’s Supplier Audit programs is to mitigate risk across our customers’ supply chains. Supplier Audits typically last one, two, or three days on-site not including audit report generation.

The right candidate must be familiar with pharmaceutical or related manufacturing processes and be thoroughly familiar with GMP/cGMP regulations (e.g. FDA cGMPs, ICH, IPEC, etc…). The auditor must have strong QMS/GMP Auditing experience having conducted many Supplier or External audits throughout his or her career.

Relevant quality standards and audit types include, but are not limited to

· FDA Regulations:

o 21 CFR part 210/211 (current Good Manufacturing Practice for Pharmaceuticals)

o 21 CFR part 820 (Medical Devices)

o 21 CFR part 11 (Electronic Records)

o 21 CFR part 58 (Good Laboratory Practices)

· Eudralex vol. 4

· Canada GMP

· ICH Q7 – Active Pharmaceutical Ingredients / APIs

· IPEC Excipient GMPs

· IPEC GDP

· ISO 13485

· ISO 17025

· ISO 9001

· WHO Guidelines

· Other international GMP guidelines

Lead Auditor Certification is desired.

SQA pays on a per-audit or per-activity basis. This position requires travel to various supplier locations. All travel and expenses are covered by SQA with approval. Pay range is $1000-$1300 per one day audit activity.