Quality Auditor - Pharmaceutical/Medical Device

Job description

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’re hiring a Pharma Quality Auditor. This is a contract opportunity in which you will perform supplier quality audits at various suppliers in Japan. 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 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 ISO 9001 - 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 and/or ISO 13485 - ISO certifications are a plus but not mandatory