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.
- 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.