Quality Assurance III – FT – Santa Ana, CA

Job Summary

  • Review batch-related documentation and ensure resolution of issues to ensure timely release of final product.
  • Ensure products are manufactured in compliance with regulatory and GMP guidelines.
  • Work with Manufacturing, Clinical Development and Quality Control as area Quality Assurance (QA) representative.
  • Provide quality assurance input and oversight in resolving manufacturing and quality operations-related issues.
  • Provide on-the-floor QA oversight and support to ensure compliance to GMP throughout the area.
  • Perform audits of raw materials and component suppliers. Work with suppliers to identify and implement responses to observations. Write audit reports and close records within target timelines.
  • Own and/or approve change controls to manage new materials and material changes.
  • Develop and assist in maintaining the audit schedule and approved supplier list for assigned suppliers.
  • Perform ongoing evaluation of quality systems that include, but are not limited to the quality audit program, vendor qualification system & the corrective action program.
  • Support inspection readiness plans and interact with regulatory agencies during inspections on quality related matters, as needed.
  • Develop & manage company standard operating procedures & company wide quality policies.
  • Develop, perform and/or oversee equipment IQ/OQ and PQ.
  • Perform other duties as assigned.

General Accountabilities

  • Work as part of a small team to ensure manufacturing is performed using GCP and GMP standards.
  • Generate COAs for product release.
  • Perform procedures and maintain accurate documentation in compliance with FDA’s Good Laboratory Practices, Good Clinical Practice, Good Manufacturing Practices.
  • Maintain and audit log books, per established procedures ensuring accuracy and timely completion.
  • Work in clean room environment, which requires specialized gowning, such as double gloves, hair net, masks, safety glasses, sterile jumpsuit and shoe covers.
  • Maintain and apply knowledge regarding patient information, screening and testing, labeling and product acceptability and release criteria.
  • Flexible and adaptable to schedule procedural changes to ensure timely preparation of products with highest quality.
  • Able to handle 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 5-6 years progressive experience in a pharmaceutical, biotechnology, or biologics operation and/or equivalent education/work experience.
  • 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 weekends, 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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