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QA Specialist

Company: Diagnostics For The Real World (drw)
Location: San Jose
Posted on: January 16, 2022

Job Description:

Diagnostics for the Real World is an ISO 13485-certified biotech company dedicated to tackling some of the worlds most serious infectious diseases using breakthrough point of care (POC) diagnostics. Our SAMBA platforms offer rapid and reliable testing in real-world settings, enabling effective disease management in the most challenging, remote, and resource-limited settings.

DRW has an immediate opening for a Quality Assurance Specialist in San Jose, CA. QA personnel will work under the supervision of the QA Manager, and will be responsible for daily quality functions.

RESPONSIBILITIES:

  • Maintain document control through review, approval, and issuance of SOPs, batch records, labels, and other controlled documents
  • Investigate and review trend deviations, OOS results, and customer complaints
  • Support equipment calibration, equipment/utility/facility validation, and preventive maintenance
  • Review data from batch records including in-process manufacturing, environmental monitoring, in-process testing, etc.
  • Participate in reviews of equipment or process qualification and product quality
  • Compile manufacturing batch records (both physical and electronic copies)
  • Log and track quality records and other documents
  • Prepare and print controlled labels for product packaging
  • Perform data entry for inventory and track completed manufacturing records
  • Other administrative duties as assigned

    DRW is an Equal Opportunity Employer. DRW does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

    Requirements

    REQUIREMENTS:
    • BA/BS degree with at least 1 year of related work experience in a GMP environment
    • Advanced knowledge and experience using MS Office, especially Word and Excel
    • Organized and detail-oriented, able to work well with timelines in a changing environment, ability to perform multiple tasks effectively and concurrently, and ability to work with minimal direction
    • Excellent customer service, effective verbal and written communication skills, high degree of professionalism, strong team player, and a positive can-do attitude

      PREFERRED REQUIREMENTS:
      • BA/BS degree in the Physical or Life Sciences with 1-3 years of related work experience in a GMP environment
      • Prior knowledge of and experience with ISO standards (9001 and 13485)

        Benefits

        BENEFITS:
        • Health Care Plan (Medical, Dental & Vision)
        • Retirement Plan (401k with matching)
        • Life Insurance (Basic, Voluntary & AD&D)
        • Paid Time Off (Vacation, Sick & Public Holidays)
        • Free Food & Snacksby Jobble

Keywords: Diagnostics For The Real World (drw), San Jose , QA Specialist, Other , San Jose, California

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