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About the Role
SQA Services is seeking a contract Supplier Quality Auditor with experience in cosmetics and pharma regulations to perform supplier audits in Japan. Audits are typically 1-2 days long, and you have the flexibility to accept or reject assignments based on your 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 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.
Requirements
- 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 210/211, EU Vol 4, ISO 22716, 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.
Skills
- Cosmetics and pharma regulations
- Audit experience
- Pharmaceutical industry
- Medical device industry
- Biologics industry
- 21 CFR 210/211
- EU Vol 4
- ISO 22716
- ISO 9001
- Communication skills
- Writing skills
- Conflict deescalation
- Adaptability to technology
- Regional travel
Location
- Japan
- Regional
Work Type
- Contract
- Remote
- Onsite
Experience Level
- 5+ years of hands-on audit experience
- Lead auditor in at least 10 audits
Salary/Compensations
- $1500 per day
Benefits
- Expenses reimbursed at cost with receipts per SQA travel policy.
- SQA assists with audit preparation.
- SQA proofreads all audit reports.
About the Company
- 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.
Equal Opportunity
- 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.