Quality Auditor - Radiopharmaceuticals

About the role

SQA Services is hiring a Supplier Quality Auditor with experience working with radiopharmaceuticals. This is a contract opportunity in which you will perform supplier quality audits at various suppliers in the Midwest. These audits are generally 1-2 days long. You are given the flexibility to accept or reject these assignments according to your own availability.

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

Required Qualifications

• 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, and Canada GMP
• Strong communication and writing skills
• Proven ability to deescalate workplace conflicts effectively
• Ability to adapt to new technology and software
• Willingness to travel regionally

Preferred Qualifications

• Direct audit experience to ISO 17025, ISO 15378, IPEC GDP, ICH Q7, ISO 13485, 21 CFR 100, and/or 21 CFR 507
• ISO certifications are a plus but not mandatory

Pay

$4100 for a 3-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. Does not include: Following up on CAPA for any findings or reimbursement for travel expenses - expenses are reimbursed at cost with receipts per SQA travel policy. Note that SQA helps with the preparation of the audit and proofreads all audit reports.