QA Specialist

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

Job Responsibilities:

• Coordinate the development and scientific material review process in the US to ensure the high volume of content
• Provide on-the-floor QA oversight and support to ensure compliance to GMP throughout the area
• Provide Quality Assurance support involving manufacturing production issues
• Ensure that company products are manufactured in compliance with site, regulatory and GMP guidelines
• Ensure timely issuance of production records and labels
• 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 company 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
• Gather metric information for use in continuous improvement of areas of responsibility, as needed
• Perform other duties as required to fulfill department and business needs

Skills and Requirements:

• Bachelor's degree in technical discipline (Biology/Chemistry/Microbiology/Engineering or related field) with a minimum of 2-4 years of experience in Quality Assurance, Quality Control, or a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility
• Working knowledge of GMP, 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

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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