QA Specialist in El Segundo, CA at Apex Life Sciences

Date Posted: 8/10/2018

Job Snapshot

Job Description


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

DUTIES AND RESPONSIBILITIES:

  • Provide Quality Assurance oversight of the commercial manufacturing of final drug product.
  • Identify and assess quality risk in activities and processes according to regulatory guidelines and Standard Operating Procedures.
  • Proficient in Quality Systems particularly associated with Operations, Product Disposition, Change Control and Deviations/CAPA.
  • Work with the Manufacturing department as a production area Quality Assurance representative.
  • Coordinate and facilitate Quality Assurance related production and production related activities.
    • Ensure timely issuance of production records, procedures and labels.
    • Perform on the floor batch record review.
    • Ensure timely assessment and closure of Deviations/CAPA and Change Controls requests.
    • Communicate lot disposition pending issues to Management.
  • Ensure that products are manufactured in compliance with regulatory and GMP guidelines.
    • Manage and perform area Person in the Plant activities.
    • Review and approve Manufacturing and Validation documents.
    • Review and approve Manufacturing Production Records.
    • Compile and verify all batch related documents into a Final Product lot disposition package.
  • Review and disposition disposable raw materials and components for GMP use.
  • Gather metric information for use in continuous improvement of areas of responsibility.
  • Provide services for Batch Record review and Product Disposition
    • Packout/shipping support
    • Deviation review/approval
    • Related activities associated with manufacturing support in preparation for the upcoming FDA and EMA Inspections, and commercial production
  • Provide services for Facilities/Utilities and Incoming support
    • Work Order review/approval, Deviation review/approval, Disposition of raw materials

REQUIREMENTS:

  • Required:  Minimum of 5-8 years of experience in Quality Assurance or a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility.  Working knowledge of quality systems and regulatory requirements.
  • Education: Bachelor’s degree in technical discipline (Biology/Chemistry/Microbiology/Engineering or similar). 
  • Quality Assurance, GMPs, Health Authority Regulations and Validation practices/principles
  • Strong knowledge of GMP, SOPs and quality systems
  • Identifying, writing evaluating and closing Deviations and CAPA
  • General knowledge of aseptic manufacturing processes
  • Experience with Change Control practices/strategies
  • Proficient in Outlook, MS Word, Excel, Power Point and other applications
  • Strong written and verbal communication skills

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.