QA Operations Specialist in El Segundo, CA at APEX Systems

Date Posted: 7/17/2019

Job Snapshot

Job Description

Job #:  963079
This is an opportunity to work with a team in supporting efforts in the exciting new area of cancer immunotherapy! We are seeking a Quality Assurance Operations Specialist II to join their team. This is a great opportunity to work for an industry leader within biopharmaceutical industry!
  • Coordinate and facilitate Quality Assurance related production, and production related activities
  • Ensure timely verification and issuance of production records, procedures and labels
  • Elevate issues affecting lot production or release to Management in a timely manner
  • Ensure approval and timely delivery of Final Product
  • Ensure that  products are manufactured in compliance with site, regulatory and GMP guidelines
  • Support quality investigations of Deviations, GMP and Quality System issues, non-conforming materials, and CAPA
  • Provide Quality Assurance support involving manufacturing production issues
  • Perform other duties as required

  • Bachelor’s degree in technical discipline (Biology/Chemistry/Microbiology/Engineering or related field) with a minimum of 1-5 years of experience in Quality Assurance, Quality Control, or a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility
  • Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211), practices/principles
  • Knowledge of ICH, USP, and Ph. Eur guidelines
  • Knowledge of GMP, SOPs and quality system
  • 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

EEO Employer
Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178-6178.