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