Sara Rose Cuviello
@sararosecuviello
Detail-oriented QA Specialist with expertise in compliance and audits.
What I'm looking for
As a QA Specialist at Alliance Medical Products, I have honed my skills in compliance and quality auditing, performing both remote and on-site vendor audits to ensure supplier qualifications for aseptic drug products. My role involves managing the vendor qualification program and conducting internal audits to uphold the highest standards in drug manufacturing.
With a B.S. in Chemistry from the University of California, Irvine, and an A.C.S. Certification, I am well-versed in quality principles and cGMP practices. My experience includes performing investigations for deviations, reviewing analytical test data, and ensuring compliance with relevant standard operating procedures. I am committed to maintaining quality and safety in the pharmaceutical industry.
Experience
Work history, roles, and key accomplishments
QA Specialist - Compliance
Alliance Medical Products - Siegfried Company
Jul 2022 - Present (2 years 10 months)
As a QA Specialist, I perform remote and on-site vendor audits for supplier qualification, manage the vendor qualification program, and conduct internal audits related to drug product manufacturing. I also investigate deviations and review analytical test data for compliance.
QA Associate II - Validations
Alliance Medical Products - Siegfried Company
Mar 2019 - Jun 2022 (3 years 3 months)
In this role, I performed sterilization process validations, monitored temperature mapping, and drafted validation protocols for aseptic drug product manufacturing. I supported process qualifications and maintenance for aseptic filling.
QA Associate - Manufacturing Support
Alliance Medical Products - Siegfried Company
Mar 2018 - Mar 2019 (1 year)
As a QA Associate, I provided in-process production support, verified laboratory samples, and reviewed drug product batch records. I also performed audits and supported labeling and packaging of finished drug products.
Hostess
Seacliff Country Club
As a Hostess, I scheduled reservations, coordinated with staff, greeted members, and handled customer complaints in a fast-paced dining environment.
Education
Degrees, certifications, and relevant coursework
University of California, Irvine
Bachelor of Science, Chemistry
Completed a Bachelor of Science in Chemistry, focusing on analytical techniques and quality assurance principles relevant to the pharmaceutical industry.
Tech stack
Software and tools used professionally
Availability
Location
Authorized to work in
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