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SQA Services

Quality Auditor / GMP Auditor

SQA Services, Chicago, Illinois, United States, 60290


SQA Services, a premier Quality Assurance and Supply Chain consultancy firm, is on the lookout for dedicated professionals to join our dynamic team. We manage Supplier Audit and Supplier Development programs for top-tier clients across diverse industries, including Pharmaceutical, Medical Device, Automotive, Aerospace, and Electronics manufacturing. By leveraging SQA's global network of Quality Professionals in over 50 countries, our clients seamlessly extend their Supplier Quality teams.

About the Role:

As a Quality Auditor at SQA, you'll play a crucial role in ensuring the highest standards of Quality System and GMP compliance. You'll conduct audits of suppliers in the Pharmaceutical or Cosmetics manufacturing industries, aiming to mitigate risks and uphold the integrity of our customers' supply chains. These audits typically span 1-3 days on-site, excluding report generation.

Key Responsibilities:

Conduct Quality System and GMP compliance audits.

Generate detailed audit reports.

Work closely with SQA headquarters and global teams.

Required Expertise:

In-depth knowledge of pharmaceutical or related manufacturing processes.

Strong familiarity with GMP/cGMP regulations (FDA cGMPs, ICH, IPEC, etc.).

Extensive QMS/GMP auditing experience with a track record of conducting numerous supplier or external audits.

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

FDA Regulations:

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

21 CFR part 820 (Medical Devices)

21 CFR part 11 (Electronic Records)

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

Qualifications:

Exceptional English communication skills, both written and verbal.

Strong audit experience with specific expertise in IPEC Excipient GMPs, ICH Q7, 21 CFR Part 210/211.

Local candidates within Ohio (OH), Indiana (IN), and Illinois (IL) are preferred.

Compensation:

Contract-based role with payment per audit.

If you're passionate about quality and compliance and eager to make a global impact, we want to hear from you! Join us at SQA Services and be a part of our mission to uphold excellence across supply chains worldwide.

Apply today to embark on an exciting career journey with SQA Services!

Job Type:

Contract

Pay:

$950.00 - $1,200.00 per day

Schedule:

8 hour shift

Day shift

Work Location:

In person

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