Quality Auditor - Pharmaceutical/Medical Device

SQA Services • Duluth, MN

4d • $1,300 - $1,300 • Remote

About The Position

SQA Services is seeking a Pharma Quality Auditor for a contract opportunity. In this role, you will perform supplier quality audits at various suppliers in Japan. These audits are typically 1-2 days long, and you will have the flexibility to accept or reject assignments based on your availability. SQA Services has been a leading provider of managed supplier quality services for nearly 30 years, offering a comprehensive suite of solutions including audits, assessments, remote surveillance, corrective actions, remediation, inspections, and engineering solutions to manufacturers across all industries. We leverage a global network of highly skilled associates to provide rapid on-site support at supplier locations worldwide.

Requirements

• 5+ years of hands-on audit experience in pharmaceutical, medical device, and/or biologics industries.
• Has been the lead auditor in at least 10 audits.
• Direct audit experience to 21 CFR part 210/211, EU Vol 4, ISO 13485, and 21 CFR 820.
• Strong communication and writing skills.
• Proven ability to deescalate workplace conflicts effectively.
• Ability to adapt to new technology and software.
• Willingness to travel regionally.

Nice To Haves

• Direct audit experience to ISO 17025, ISO 15378, IPEC GDP, ICH Q7 and/or Canada GMP.
• ISO certifications are a plus but not mandatory.

Responsibilities

• Perform supplier audits at various sites within your region of residence.
• Assure quality in the supply chains of various clients within the pharmaceutical, medical device, cosmetics, biologics, and/or animal health industries.
• Coordinate, prepare, execute, and deliver supplier audits based on your own and the client schedule.
• Utilize your regulatory knowledge of various standards from ISO, CFR, FDA, etc.
• Respond to the Content team in a timely manner regarding edits/questions to your audit report.
• Write audit reports in accordance with client specifications.

Benefits

• Pay Rate: $1300 for a 1-day audit.
• Includes: Time spent preparing for the audit, traveling, performing the audit, writing the report, and responding to questions from our Content team of editors and the client until the report is finalized.
• Expenses are reimbursed at cost with receipts per SQA travel policy.

What This Job Offers

• Career Level: Senior
• Education Level: No Education Listed