Salary
💰 $200 - $213 per hour
About the role
- Perform supplier audits at various sites within Japan
- Assure quality in the supply chains of clients in animal health, pharmaceutical, medical device, cosmetics, and/or biologics industries
- Coordinate, prepare, execute, and deliver supplier audits based on your own and the client schedule
- Utilize regulatory knowledge of standards such as ISO, CFR, FDA, EU GMP, ICH Q7
- Respond to the Content team in a timely manner regarding edits/questions to your audit report
- Write audit reports in accordance with client specifications
Requirements
- 5+ years of hands-on audit experience in animal health, pharmaceutical, medical device, cosmetics, and/or biologics industries
- Direct audit experience to 21 CFR part 210/211, EU GMP, EU Vol 4, ISO 9001, and ICH Q7
- Strong communication and writing skills
- Proven ability to deescalate workplace conflicts effectively
- Ability to adapt to new technology and software
- Willingness to travel
- Preferred: Strong experience with 21 CFR part 58, 21 CFR part 820, EU GDP, ISO 15378, ISO 17025
- Preferred: ISO certifications are a plus but not mandatory
- Flexible scheduling: ability to accept or reject assignments according to your availability
- Reimbursement of travel expenses at cost with receipts per SQA travel policy
- SQA provides audit preparation support and proofreads audit reports
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
audit experienceregulatory knowledgeISO 900121 CFR part 21021 CFR part 211EU GMPICH Q7ISO 15378ISO 1702521 CFR part 58
Soft skills
strong communication skillswriting skillsconflict deescalationadaptabilitytime management
Certifications
ISO certifications