Quality Auditor - Pharmaceutical/Medical Device at SQA Services

Algoma, Wisconsin, United States -

Full Time

Start Date

Immediate

Expiry Date

11 Aug, 26

Salary

1300.0

Posted On

13 May, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Supplier Quality Auditing, Regulatory Compliance, Audit Report Writing, Conflict De-escalation, ISO 13485, 21 CFR Part 210/211, 21 CFR 820, EU Vol 4, Pharmaceutical Quality Assurance, Medical Device Auditing

Industry

Business Consulting and Services

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. \n 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, ISO 13485, and 21 CFR 820 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 Canada GMP ISO certifications are a plus but not mandatory \n $1,300 - $1,300 a day Pay Rate: $1300 for a 1-day audit. Includes: Time spent preparing for the audit, traveling, performing the audit, writing the report, and responding to questions from our Content team of editors and the client until the report is finalized. Does not include: Following up on CAPA for any findings or reimbursement for travel expenses - expenses are reimbursed at cost with receipts per SQA travel policy. Note that SQA helps with the preparation of the audit and proofreads all audit reports. \n 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. #ZR

Responsibilities

Perform and coordinate supplier quality audits for clients in the pharmaceutical, medical device, and biologics industries. Prepare and deliver detailed audit reports based on regulatory standards and client specifications.