QA Associate in Santa Monica, CA at Apex Life Sciences

Date Posted: 5/30/2018

Job Snapshot

Job Description


A well-regarded company focusing on patient therapies is seeking a QA Associate to join their team. This is a great opportunity to work for an industry leader!

DUTIES AND RESPONSIBILITIES:

  • Work with the Manufacturing department as a production area Quality Assurance representative
  • Coordinate and facilitate Quality Assurance related activities in support of production:
    • Ensure timely issuance of production records  and in-process and final product labels
    • Review and approve batch-related documentation, and ensure resolution of issues to release product
    • Compile and verify all batch related documents into a Final Product lot disposition package
    • Communicate lot disposition pending issues to Management
  • Ensure that products are manufactured in compliance with regulatory and GMP guidelines
  • Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues
  • Ensure orderliness of the QA Ops areas of responsibilities such as the accession room and batch record review room
  • Support apheresis accession, as needed
  • Perform incoming label inspection
  • Gather metric information for use in continuous improvement of areas of responsibility. Report to management as needed
  • Perform other duties as required

REQUIREMENTS:

  • College level education in Biological Sciences or related field
  • Minimum of 1 year Quality and/or Manufacturing experience in a FDA-regulated industry (pharmaceutical, biotech, biologics or medical device operation)
  • Working knowledge of GMPs in conformance to U.S. standards
  • Proficient in MS Word, Excel, Power Point and other applications
  • Ability to effectively negotiate and build collaboration amongst individuals
  • Strong interpersonal, verbal and written communication skills Ability to communicate and work independently with scientific/technical personnel
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on changing priorities

Preferred Qualifications: (In addition to the Requirements above)

  • Bachelor’s degree in Biological Sciences or related field
  • 2-3 years Quality and/or Manufacturing experience in a FDA-regulated industry (pharmaceutical, biotech, biologics or medical device operation)
  • Working knowledge of Quality Systems and ability to apply GMPs in conformance to U.S. and EU standards
  • Experience with manufacturing investigations, Deviations, and CAPA
  • Experience with Change Control practices and strategies
  • General knowledge of aseptic manufacturing processes
  • Knowledge of equipment, facility, and utility IQ/OQ/PQ

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 employeeservices@apexsystemsinc.com or 844-463-6178.