Quality Auditor - Pharmaceuticals (1-2 Day Audits)

For nearly 30 years, SQA Services has been a leading provider of managed supplier quality services, offering audits, assessments, remote surveillance, corrective actions, remediation, inspections, and engineering solutions to manufacturers across all industries. We deliver these services by deploying a network of highly skilled associates based throughout the United States and in over 90 countries worldwide, ensuring rapid on-site support at your supplier locations. Our associates are expert quality assurance professionals with extensive experience and local expertise, enabling us to represent our clients on demand and with greater speed and efficiency than our competitors. We are seeking an experienced Pharmaceutical Quality Auditor based in the Midwest/East Coast region of the United States to perform supplier audits for pharmaceutical commodities, including raw materials, excipients, packaging materials, and APIs. This is a contract position offering flexibility—you may accept or decline audit assignments according to your own schedule. The ideal candidate has served as a Lead Auditor for 10+ audits in accordance with 21 CFR 210/211 and possesses familiarity with IPEC-PQG GMP, IPEC GDP, ICH Q7, and/or ISO 15378 standards.

Key Responsibilities

• Conduct 1–2 day on-site supplier audits at pharmaceutical manufacturing and packaging facilities across the Midwest, Northeast, and Southeast U.S.
• Evaluate supplier compliance to GMP and regulatory requirements under 21 CFR 210/211, IPEC, and ICH Q7 frameworks.
• Prepare detailed audit plans, execute audits, and document findings accurately and thoroughly.
• Assess supplier quality systems for pharmaceutical raw materials, excipients, APIs, and packaging.
• Collaborate with SQA’s internal content and quality teams to ensure all reports meet client specifications.
• Communicate findings effectively with suppliers and clients, maintaining a professional and solutions-oriented approach.
• Submit final audit reports and respond to follow-up questions promptly and professionally.

Required Qualifications

• Minimum 5 years of auditing experience within the pharmaceutical manufacturing industry.
• Must have conducted 10 or more audits as a Lead Auditor under 21 CFR 210/211.
• Proven knowledge of IPEC-PQG GMP, IPEC GDP, ICH Q7, and/or ISO 15378.
• Excellent verbal and written communication skills.
• Ability to manage multiple audits and meet client deadlines.
• Strong audit reporting and documentation abilities.
• Availability for at least two audits per month.
• Willingness to travel within the Midwest, Northeast, and Southeast regions.

Preferred Qualifications

• Experience auditing to EU GMP and other global pharmaceutical standards.
• Familiarity with packaging suppliers, excipient manufacturers, or API producers.
• Current or prior ISO Lead Auditor Certification (ISO 9001, ISO 15378, etc.).
• Experience auditing to 21 CFR 820 (medical devices) or ISO 13485 is a plus.

$1,500 - $1,700 a day $1,500 – $1,700 USD per day (inclusive of preparation, travel time, audit execution, reporting, and revisions). Travel expenses reimbursed at cost with receipts per SQA policy. Flexible engagement — you choose which audits to accept based on your availability. Note: SQA is an Equal Opportunity Employer. Employment is based on merit and qualifications, and is not influenced by race, color, religion, gender, national origin, veteran status, disability, age, sexual orientation, gender identity, marital status, or any other legally protected status.​ This position requires access to ITAR-controlled technical data and/or defense articles. As such, the candidate must be a U.S. citizen or U.S. lawful permanent resident (green card holder) to comply with the International Traffic in Arms Regulations (ITAR). Applicants who do not meet these criteria will not be considered for this role. #ZR Apply tot his job Apply To this Job