Quality Auditor - Pharmaceutical & Food

SQA Services • Boston, MA

4d • Remote

About The Position

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 Quality Auditor who has direct experience working in both the pharma and food industries. This is a contract opportunity in which you will perform supplier quality audits at various suppliers in the northeastern region of the US. These audits are generally 1-2 days long. You are given the flexibility to accept or reject these assignments according to your own availability.

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 part 210/211, EU Vol 4, Canada GMP, 21 CFR 111, 21 CFR 117 and/or 21 CFR 121
• Strong communication and writing skills
• Proven ability to deescalate workplace conflicts effectively
• Ability to adapt to new technology and software.
• Willingness to travel regionally

Nice To Haves

• Direct audit experience to ISO 17025, ISO 15378, 21 CFR 110, 21 CFR 120, 21 CFR 507
• ISO certifications are a plus but not mandatory

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

Benefits

• 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.
• Expenses are reimbursed at cost with receipts per SQA travel policy.
• SQA helps with the preparation of the audit and proofreads all audit reports.

What This Job Offers

• Career Level: Senior
• Education Level: No Education Listed