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Job type: Permanent

Discipline: Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP)

Location: United States

Proclinical is currently recruiting for a QA Specialist with a pharmaceutical company located in El Segundo, CA.

Job Responsibilities:

Provide on-the-floor QA oversight and support to ensure compliance to GMP throughout the area.
Ensure that company products are manufactured in compliance with site, regulatory and GMP guidelines.
Elevate issues affecting lot production or release to Management in a timely manner.
Ensure approval and timely delivery of Final Product.
Review and approve executed Manufacturing Production Records for regulatory and site compliance.
Compile and verify all batch-related documents into a Final Product lot disposition package.
Perform quality review and/or investigations of manufacturing deviations, GMP and Quality.
System issues, non-conforming materials, and CAPA, as needed

Skills and Requirements:

Bachelor's degree in relevant field with at least 3 years of experience.
Working knowledge of GMP, quality systems and regulatory requirements (21 CRF Part 11/210/211/600/610), practices/principles.
Knowledge of relevant ICH and FDA guidance documents.
Experience in identifying deviations and CAPA.
General knowledge of aseptic manufacturing processes.
Proficient in MS Word, Excel, Power Point and other applications.
Strong written and verbal communication skills.
Ability to communicate and work independently with scientific/technical personnel.
Experience with internal and external audit and knowledge of IQ/OQ/PQ is a plus

If you are having difficulty in applying or if you have any questions, please contact Catherine Nguyen at 215-531-5643.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-CN1

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