Quality Auditor

Supplier Quality AuditorFor 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're hiring a Supplier Quality Auditor who has 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.Key ResponsibilitiesPerform supplier audits at various sites within your region of residenceAssure quality in the supply chains of various clients within the pharmaceutical, medical device, cosmetics, biologics, and/or animal health industriesCoordinate, prepare, execute, and deliver supplier audits based on your own and the client scheduleUtilize your regulatory knowledge of various standards from ISO, CFR, FDA, etcRespond to the Content team in a timely manner regarding edits/questions to your audit reportWrite audit reports in accordance with client specificationsRequired Qualifications5+ years of hands-on audit experience in pharmaceutical, medical device, and/or biologics industriesHas been the lead auditor in at least 10 auditsDirect audit experience to 21 CFR part 210/211, EU Vol 4, and Canada GMPStrong communication and writing skillsProven ability to deescalate workplace conflicts effectivelyAbility to adapt to new technology and softwareWillingness to travel regionallyPreferred QualificationsDirect audit experience to ISO 17025, ISO 15378, IPEC GDP, ICH Q7, ISO 13485, 21 CFR 100, and/or 21 CFR 507ISO certifications are a plus but not mandatoryPay Rate: $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. 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. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.