QA Specialist

Highly Competitive Salary
  1. Permanent
  2. Good Manufacturing Practice (GMP)
  3. United States
El Segundo, USA
Posting date: 08 Jun 2020

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.