QA Specialist

Proclinical is currently recruiting for a QA Specialist with a pharmaceutical company located in El Segundo, CA. A successful candidate will have a bachelor's degree of higher with minimum of 3 years of relevant experience, knowledge of GMP, experience with identifying deviations and CAPAs, and knowledge of aseptic manufacturing processes.

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.

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