Supplier Quality Assurance Auditor

2 weeks ago


New York, New York, United States SQA Services Full time
Company Overview:

SQA Services is a prominent consultancy specializing in Quality Assurance and Supply Chain management. We provide comprehensive Supplier Audit and Development programs across various sectors, including Pharmaceuticals, Medical Devices, Automotive, Aerospace, and Electronics manufacturing.

Our clients benefit from SQA's extensive network of Quality Professionals operating in over 50 countries, effectively augmenting their Supplier Quality teams.

Position Title:

Quality Auditor / GMP Auditor

Role Summary:

The Quality Auditor will be tasked with conducting audits to ensure compliance with Quality Systems and Good Manufacturing Practices (GMP) for Suppliers in the Pharmaceutical and Cosmetics sectors.

The primary objective of SQA's Supplier Audit initiatives is to minimize risks within our clients' supply chains. Audits generally require 1-3 days on-site, excluding the time needed for report preparation. Ideal candidates should possess a solid understanding of pharmaceutical manufacturing processes and be well-versed in GMP/cGMP regulations, including FDA cGMPs, ICH, and IPEC standards.

Key Responsibilities:
  • Conduct thorough Supplier and External audits, leveraging extensive QMS/GMP auditing experience.
  • Familiarity with relevant quality standards and audit types, such as:
    • FDA Regulations: 21 CFR part 210/211, 21 CFR part 820, 21 CFR part 11, 21 CFR part 58
    • Eudralex vol. 4
    • Canada GMP
    • ICH Q7 – Active Pharmaceutical Ingredients
    • IPEC Excipient GMPs and GDP
    • ISO 13485, ISO 17025, ISO 9001
    • WHO Guidelines and other international GMP standards

The Quality Auditor must demonstrate excellent English communication skills, both written and verbal.

This role involves collaboration with personnel from SQA Services' headquarters, with the flexibility to work remotely from any location.

This position operates on a contract basis, with compensation provided per audit conducted. Travel to various supplier sites is a requirement, with all travel expenses covered by SQA Services upon approval.

The compensation range for a one-day audit, including preparation assistance and report proofreading, is between $1000 and $1200.



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