SQA Services, Inc.

Quality Auditor - Pharmaceutical

Reposted 2 Days Ago

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2 Locations

In-Office or Remote

Senior level

Consulting

The Role

The Pharma Quality Auditor will conduct supplier audits for pharmaceutical and related industries, ensuring compliance with quality standards and regulatory requirements, while managing audit schedules and reporting findings.

Summary Generated by Built In

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

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.

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The Company

HQ: Palos Verdes Peninsula, California

350 Employees

Year Founded: 1995

What We Do

Welcome to the SQA Services, Inc. home on LinkedIn! Follow us to stay up to date on all things quality - including industry events, news, and ways to get involved with #TeamSQA. Also, keep an eye out for job postings! SQA is always looking for quality professionals and new team members! WHAT IS SQA SERVICES, INC.? SQA provides global supplier quality services for quality-critical industries. With quality, manufacturing, and regulatory experts located in over 50 countries, SQA provides a cost-effective, local supplier presence. Managed, on-demand services include supplier quality audits, supplier remediation, quality engineering, source inspection, corrective action management, and real-time supplier quality data via SQA's world-class STEPQ technology. HOW CAN I GET IN TOUCH WITH SQA? We look forward to connecting with you and discovering how Team SQA can help you and your team reach your quality goals. Contact our team by heading over to http://www.sqaservices.com/contact If you think you or someone you know would be a great fit for our team, please send your resume to our Associate Development team at: [email protected]