CAREER OPPORTUNITY: Quality Assurance Specialist

JOB DESCRIPTION:

ZebraSci is a privately held company that supports pharmaceutical & medical device development and testing. We are seeking a detail oriented and enthusiastic Quality Assurance Specialist for our state-of-the-art ISO-accredited corporate laboratory located in Temecula, CA

The Quality Assurance Specialist oversees the development and implementation of the company’s quality systems (cGMP’s & ISO 17025) by ensuring that all testing work completed by the laboratory is in accordance with client specifications, the company’s standard operating procedures and regulatory agencies regulations.

ESSENTIAL DUTIES & RESPONSIBILITIES:
  • Ensure compliance to applicable regulations (cGMP, ISO/IEC 17025)
  • Develop and perform cGMP and ISO/IEC 17025 training
  • Coordinate and professionally respond to client quality concerns
  • Manage the document and record control process
  • Perform data review to ensure accuracy of test reports; QA approval for test reports and associated documentation
  • Support the process for execution, investigation and documentation for deviations, OOS, complaints and non-conformances
  • Manage the overall CAPA program to include investigation, root cause analysis, corrective and preventative actions and documentation
  • Conduct internal audits; determine and execute the corrective actions
  • Conduct customer/ regulatory audits; determine and implement effective corrective actions
  • Write and implement required SOP’s and work instructions
  • Maintain laboratory instrumentation calibration and maintenance program
  • Maintain electronic Quality Management System (eQMS)
    Hours: Full-time; Monday – Friday between 8:00am and 5:00pm
QUALIFICATIONS:
  • Requires a bachelor’s degree in a science or business field or equivalent work experience.
  • Prior experience (3 years or more) in Quality Assurance or Quality Control
  • Knowledge of cGMP regulations (preferably 21 CFR part 211) and ISO/IEC 17025
  • Advanced skills in Microsoft Office: Word, Excel, Power Point
  • Excellent communication skills to be able to communicate effectively and in a professional manner
  • Excellent written and verbal communication skills
  • Strong organizational skills that reflect ability to perform and prioritize multiple tasks seamlessly with excellent attention to detail and communication
  • The ability to work independently as well as contribute successfully within a team environment
  • Confident decision maker, owns responsibility for outcomes
  • Delivers tasks and deadlines, meeting all deadlines
  • Ability to write technical reports, taking facts and information and assembling them into a logical report with well supported conclusions and summaries.
  • Experience with electronic Quality Management System (eQMS) and Laboratory Information Management Systems (LIMS)

APPLY HERE:

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