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NKMax America Inc

Quality Assurance

CMC · Santa Ana, California
Department CMC
Employment Type Full-Time
Minimum Experience Mid-level

 

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.
  • 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.
  • Perform other duties as assigned.

General Responsibilities 

 

  • Work as part of a small team to ensure manufacturing is performed using GCP and GMP standards.
  • Generates 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 that requires specialized gowning such as double gloves, hair net, masks, safety glasses, sterile jumpsuit and shoe covers.
  • Must 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.
  • Handle human blood and human blood base product.
  • Other duties as assigned.

 

Job Qualifications & Skills

 

  • 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 highly preferred.
  • Experience in identifying, writing, evaluating and closing investigations. Experience with investigations, deviations, and 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.
  • 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.

 

Thank You

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  • Location
    Santa Ana, California
  • Department
    CMC
  • Employment Type
    Full-Time
  • Minimum Experience
    Mid-level