Quality Assurance Analyst – Batch Record Review

By | September 7, 2024

Quality Assurance Analyst - Batch Record Review

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Job ID: 9531868

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Lodi, CA, US

Scientific

Unspecified

Full Time, Temporary

$26.46/Hour (non-negotiable)

Experienced (Non-Manager)

On-site

Biotechnology/Pharmaceuticals

First Shift (Day)

Lodi, CA, US

$26.46/Hour (non-negotiable)

Experienced (Non-Manager)

Full Time, Temporary

Biotechnology/Pharmaceuticals

On-site

Scientific

Unspecified

First Shift (Day)

Apply Now Applied

Job details

PLEASE NOTE: Must be authorized to work lawfully in the United States for any employer without sponsorship. For immediate consideration, please (1) apply and (2) email your resume directly to: Regan.Brown@KellyScientific.com.

Kelly® Science & Clinical is seeking a Quality Systems Specialist I for temporary position (with potential to extend/convert) at a leading client in Lodi, CA. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Pay Rate:
$26.46/Hour (non-negotiable)

Overview:
The Quality Systems Specialist is responsible for reviewing records to comply with QSR and ISO requirements. They make recommendations for improvement and create training materials and operating manuals. This person is involved with various quality continuous improvement activities.
This position is part of the Quality Systems Specialist I and will be located in Lodi, CA.

Schedule:

  • Team A: Sunday/Monday/Tuesday/Every Other Wednesday, Day: 5:00 AM – 5:00 PM

    • Week 1: Sunday/Monday/Tuesday

    • Week 2: Sunday/Monday/Tuesday/Wednesday


  • Team B: Thursday/Friday/Saturday/Every Other Wednesday, Day: 5:00 AM – 5:00 PM

    • Week 1: Wednesday/Thursday/Friday/Saturday

    • Week 2: Thursday/Friday/Saturday


  • Team C: Sunday/Monday/Tuesday/Every other Saturday, Day: 5:00 AM – 5:00 PM

    • Week 1: Sunday/Monday/Tuesday

    • Week 2: Saturday/Sunday/Monday/Tuesday


  • Team D: Wednesday/Thursday/Friday/Every Other Saturday, Day: 5:00 AM – 5:00 PM

    • Week 1: Wednesday/Thursday/Friday/Saturday

    • Week 2: Wednesday/Thursday/Friday

Responsibilities:
In this role, you will have the opportunity to:

  • Collaborating with manufacturing department for scheduling line clearance and line set up activities.

  • Verify line clearance and line set-up activities by signing in relevant sections of  documents. 

  • Reviewing the batch records online, if necessary.

  • Review records and documents, for completeness and compliance with QSR and ISO requirements.

  • Review batch record to support release of raw materials, work in progress and final products. This includes reagents, components and instrumentation-related products to ensure they are on the right path.

  • Generate standard operating procedures to define and improve quality system functions.

Qualifications:
The essential requirements of the job include:

  • High school diploma with at least 2 years of work experience in a manufacturing environment.

  • Must be familiar with ISO standards and applicable regulatory requirements (CE/FDA/QSR) and GDP.

  • Ability to interface well with people of varied backgrounds, and to guide groups toward effective dynamics.

It would be a plus if you also possess previous experience in:

  • Experience in DNA diagnostics or other medical devices.

What Happens Next:
Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.

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