Full-Time
Quality Auditor
Radiopharmaceuticals
SQA Services
201-500 employees
Global quality management for supply chains
Compensation Overview
$4.1k/mo
Indianapolis, IN, USA
In Person
Regional travel within the Midwest is required.
 Manufacturing Quality & Test (1) |
|---|
Get referred to SQA Services
See people who can refer or advise you
- At least 5 years of hands-on audit experience in pharmaceutical, medical device, and/or biologics industries.
- Served as the lead auditor for at least 10 audits.
- Direct audit experience with 21 CFR Part 210/211, EU Volume 4, and Canada Good Manufacturing Practices.
- Strong communication and writing skills.
- Ability to de-escalate workplace conflicts effectively.
- Ability to adapt to new technology and software.
- Willingness to travel regionally.
- Perform supplier audits at various sites within the auditor's region of residence.
- Assure quality in client supply chains across pharmaceutical, medical device, cosmetics, biologics, and/or animal health industries.
- Coordinate, prepare, execute, and deliver supplier audits according to the auditor's and client's schedules.
- Apply regulatory knowledge of standards from the International Organization for Standardization, Code of Federal Regulations, and Food and Drug Administration.
- Respond to the Content team in a timely manner regarding edits and questions about audit reports.
- Write audit reports according to client specifications.
- Direct audit experience with ISO 17025, ISO 15378, IPEC GDP, ICH Q7, ISO 13485, 21 CFR 100, and/or 21 CFR 507.
- ISO certifications.
SQA Services provides quality management solutions for complex, regulated supply chains by acting as an extension of its clients’ quality organizations across the globe. It serves high-tech manufacturing, aerospace, defense, pharmaceuticals, medical devices, and biologics, using a data-driven, risk-based approach to ensure supplier quality and regulatory compliance. The company performs services such as supplier quality management, quality audits and inspections, supplier development, and risk management under service contracts with Fortune 500 clients. Its global footprint allows it to monitor and manage supply chain quality in every country where clients operate, helping them save time and money while maintaining high quality standards. CEO Michael Guymon leads a flexible, integrated approach that borrows best practices from industries like automotive and aerospace to scale quality management as needs grow.
Company Size
201-500
Company Stage
M&A
Total Funding
$282M
Headquarters
null
Founded
1995
Get referred to SQA Services
See people who can refer or advise you
Simplify's Take
What believers are saying
- SQA promoted PDA Week 2026 and ASQ defense forums, signaling active pipeline generation.
- July 2026 site updates show ongoing productization around STEPQ and new lifecycle quality workshops.
- 2026 job postings for pharma auditors and aerospace SMEs indicate demand across regulated verticals.
What critics are saying
- Contractor-heavy delivery depends on scarce inspectors; July 2026 recruiting shows staffing fragility.
- Customers can internalize supplier quality with ERP and AI tools, cutting SQA’s services revenue by 2027.
- A major quality failure at an SQA-managed supplier triggers litigation, contract losses, and brand damage.
What makes SQA Services unique
- STEPQ gives clients real-time supplier quality visibility across audits, CAPA, inspections, and engineering.
- SQA deploys experts in 90+ countries, embedding local quality staff at supplier sites.
- Thirty years of supplier-quality focus spans aerospace, defense, pharma, and medical devices.
Help us improve and share your feedback! Did you find this helpful?
Benefits
Health Insurance
Dental Insurance
Vision Insurance
401(k) Retirement Plan
Paid Holidays
Paid Sick Leave
Company News
Meet SQA at PDA Week 2026. SQA Services is excited to announce its participation in PDA Week 2026, a premier event for leaders across pharmaceutical manufacturing, taking place March 22-27 in Denver, Colorado. PDA Week brings together quality, manufacturing, and regulatory professionals to address the evolving challenges facing the life sciences industry, from compliance and supplier oversight to innovation and operational performance. Strengthening quality in pharmaceutical manufacturing. In today's highly regulated environment, pharmaceutical organizations are under increasing pressure to ensure product quality, maintain compliance, and manage risk across global supply chains. SQA Services supports pharmaceutical manufacturing companies with scalable, on-demand quality solutions that extend directly into the supply base. Its capabilities include: * GMP audits and supplier assessments to ensure compliance and readiness * On-site source inspections and containment support to protect product quality * CAPA (Corrective and Preventive Action) management to identify root causes and drive sustainable improvements * Quality engineering support to strengthen processes and improve execution By embedding experienced quality professionals at supplier sites, SQA delivers real-time visibility and control - helping organizations prevent issues before they impact production and patient safety. Meet SQA Services at Booth #419. If you're attending PDA Week, SQA Services, Inc. invite you to visit SQA Services at Booth #419 to learn how SQA Services, Inc. support quality and compliance across pharmaceutical manufacturing operations. Whether you're focused on strengthening your CAPA processes, improving supplier performance, or scaling quality oversight globally, its team is ready to connect. Stop by Booth #419 or reach out to schedule a meeting with its team ahead of the event. SQA Services, Inc. look forward to connecting with you in Denver!
Last week, SQA Services attended the Parenteral Drug Association (PDA) Regulatory Conference in Washington, D.C., where regulators, quality leaders, and industry experts gathered to share perspectives on compliance, inspection readiness, and digital transformation in life sciences.
PALOS VERDES ESTATES, Calif., Oct. 5, 2023 /PRNewswire/ -- SQA Services, Inc., a leading provider of quality management solutions, is proud to announce the release of their latest white paper, an insightful exploration of the Process Failure Mode and Effects Analysis (PFMEA) methodology. PFMEA is a powerful tool used to evaluate and enhance processes across industries, offering a roadmap to improved quality, efficiency, and cost-effectiveness.A basic PFMEA procedure involves:Assembling a cross-functional team with diverse knowledge of the process. Defining the scope of the PFMEA. Identifying subprocesses within the general process. Documenting identifying information at the top of the PFMEA form
PALOS VERDES, Calif. , Sept. 25, 2023 /PRNewswire/ - SQA Services Inc., a global leader in supplier quality, is excited to announce the launch of its captivating four-episode podcast series titled "You Won't Believe What We've Seen."
PALOS VERDES, Calif., Sept. 25, 2023 /PRNewswire/ -- SQA Services Inc., a global leader in supplier quality, is excited to announce the launch of its captivating four-episode podcast series titled "You Won't Believe What We've Seen." This engaging series offers an insider's perspective on the industries SQA serves, including the aerospace, pharmaceutical, technology, and consumer sectors.The podcast series, available for streaming on our website, takes listeners on an informative and entertaining journey through the diverse landscapes of these industries and how SQA has continuously ensured patient and consumer safety. Each episode delves into the unique challenges, innovations, and insights that SQA Services Inc. brings to the table as a trusted supplier quality partner.In "You Won't Believe What We've Seen," our chairman Mike McKay and some of our top experts and advisors share their extensive knowledge and experiences, shedding light on the critical role supplier quality plays in today's dynamic business environment. Listeners can expect to gain valuable insights into industry-specific best practices, risk mitigation strategies, the history of SQA Services, Inc., and the latest trends that impact supplier quality management.SQA Services Inc., with its global footprint spanning over 90 countries, remains committed to delivering unparalleled support to clients and their suppliers worldwide. SQA provides outsourced supplier management programs for quality-critical industries, including fully managed programs for audits, assessments, engineering, source inspection, corrective action management, and remediation