Quality Assurance Specialist I
$75k/y-$85k/y
SOFIE3 months ago
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OnsiteContractorEntry
Summary
SOFIE is seeking a Quality Assurance Specialist I to join their team in Totowa, New Jersey. The role involves overseeing the Quality Assurance program and the Quality Management System at the site level.
About the Role
As a Quality Assurance Specialist I, you will maintain oversight of the QA program and Quality Management System at a SOFIE manufacturing facility. Your responsibilities will include applying quality assurance processes, writing and reviewing procedures, conducting audits, liaising with inspectors, and ensuring compliance with FDA regulations. You will also oversee the examination of incoming materials, ensure proper training of personnel, and manage the site-level change control process.
About You
Required:
- AS Degree in a related field with 2+ years of experience in Quality Assurance or Document Control in an FDA regulated environment.
- Ability to write, review, and revise SOPs.
- Proficiency in MS Office applications.
- Strong interpersonal communication skills.
Preferred:
- Experience in pharmaceutical operations.
- Knowledge of USP, FDA, and cGMP regulations.
Benefits
- Competitive salary ranging from $75,000 to $85,000 per year based on experience and education.
- Opportunity to work in a dynamic and innovative environment.
SOFIE
Our vision is to improve patient outcomes by developing and delivering molecular diagnostics and therapeutics (theranostics). With our robust radiopharmaceutical production and distribution network, mature contract manufacturing services, and now, high-value radiopharmaceutical intellectual, property, we are poised to deliver on the promise of radiopharmaceuticals. www.sofie.com www.twitter.com/sofiebio www.instagram.com/sofiebio
Totowa, NJ