Quality Auditor - Pharmaceutical & Food

SQA Services•Boston, MA

2d•Remote

About The Position

SQA Services is seeking a Quality Auditor with direct experience in both the pharmaceutical and food industries for a contract opportunity. The role involves performing supplier quality audits at various suppliers in the northeastern region of the US. These audits are typically 1-2 days long, and auditors have the flexibility to accept or reject assignments based on their availability. SQA Services has been a leading provider of managed supplier quality services for nearly 30 years, offering a wide range of quality assurance solutions to manufacturers globally.

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 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.