Quality Assurance I – FT – Santa Ana, CA

Job Summary

  • Review batch-related documentation and ensure resolution of issues to ensure timely release of final product.
  • Work with Manufacturing, Clinical Development and Quality Control, as area Quality Assurance (QA) representative.
  • Perform other duties as assigned.

General Accountabilities

  • Work as part of a small team to ensure manufacturing is performed using GCP and GMP standards.
  • Maintain and audit log books, per established procedures ensuring accuracy and timely completion.
  • Flexible and adaptable to schedule procedural changes to ensure timely preparation of products with highest quality.
  • Possible contact with human blood and human blood base product.Other duties as assigned.

Job Qualifications

  • Education: Bachelor’s degree in biochemistry or related biological field and minimum of 3-5 years progressive experience in a pharmaceutical, biotechnology, or biologics operation and/or equivalent education/work experience. Master’s degree in a related science for a minimum of 4 + years a highly preferred.
  • Experience in identifying, writing, evaluating and closing investigations. Experience with investigations, deviations, CAPA, as well as with internal and external audits.
  • Working knowledge of and ability to apply Good Manufacturing Practice (GMP) in conformance to US FDA standards.
  • Highly detail oriented and excellent interpersonal skills within collaborative work environment.
  • If required, ability to work on weekend, off-shift and long hours.
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
  • Strict adherence to SOP’s and cGMP regulations, the ability to accurately complete documentation associated with clinical manufacturing.
  • Self-motivated and willing to accept responsibilities outside of initial job description.
  • Ability to lift over 30lbs.

Skills

  • Excellent technical skills; Microsoft Word, Excel and Data Analysis.
  • Exceptional time management, problem solving and organization skills.
  • Outstanding interpersonal skills, verbal and written communication, in collaborative work environment setting.
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