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QA Specialist - 17483

Simply Biotech
Gardena, CA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

QA Specialist- Simply Biotech


Are you looking for a new career opportunity with an exciting biotech company?! Then we've got the right team for you! In this role, you're responsible for the duties listed below.

Immediate opening for a QA Specialist, in Gardena, CA who possesses:

  • Bachelor's degree
  • 5 years of experience within pharmaceutical, biotech, medical device, nutraceutical, or chemical manufacturing
  • Experience with deviations, investigations, customer complaints, supplier issues
  • FDA audit, or regulatory audit, or OSHA experience

Full Job Description:

The selected candidate will be responsible for:

  • Assist customers with various quality documentation requests regarding Company's Quality Management System.
  • Assist the Company's Sales team by providing quality-related documentation as requested.
  • Assist in assuring that the company's operates in accordance to current Good Manufacturing Practices & regulations and in compliance to ISO 9001:2015 Quality standards.
  • Complete Customer Quality Surveys & Questionnaires
  • Coordinate Quality / Technical data requests: such as Customer Spec Sheets, or Certificates of Origin, Stability Data, GMP Certifications, etc.
  • Perform Internal Quality Audits
  • Assist in hosting Customer Quality System Audits and or Regulatory Inspections
  • Qualification Program
  • Evaluating supplier self-audit questionnaire
  • Performing site quality system audits
  • Tracking supplier performance
  • Responsible for Supplier Corrective Action Request (SCAR)
  • Establishment of Quality Agreements/Clauses
  • Supply chain resolution
  • Maintain and monitor CofA challenge
  • Maintain Customer Change Control Program and Notification Support to affected parties
  • Assist with quality investigations

The selected candidate will also possess:

  • Knowledge of Quality System requirements of ISO 9001:2015, current Good Manufacturing Practices 21 CFR 210& 211, IPEC PQG, and ICH Q7/A
  • Must have basic computer literacy including familiarity of programs such as Word, Excel and Pagemaker, Filemaker
  • Lean process improvement and Six Sigma, 5 S experience and background preferred


Salary Range: $65k-$95k/yr
For immediate and confidential consideration, please email your resume to or call 469.895.5514
More information can be found at

Simply Biotech


Gardena, CA




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