Quality Systems Specialist - Batch Record Review

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 : [email protected] .

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 :

• Day Shift : $26.46 / Hour (non-negotiable)
• Night Shift : $29.37 / 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 : 6 : 00 AM 6 : 00 PM
• Week 1 : Sunday / Monday / Tuesday
• Week 2 : Sunday / Monday / Tuesday / Wednesday
• Team B : Thursday / Friday / Saturday / Every Other Wednesday, Day : 6 : 00 AM 6 : 00 PM
• Week 1 : Wednesday / Thursday / Friday / Saturday
• Week 2 : Thursday / Friday / Saturday
• Team C : Sunday / Monday / Tuesday / Every other Saturday, Night : 6 : 00 PM 6 : 00 AM
• Week 1 : Sunday / Monday / Tuesday
• Week 2 : Saturday / Sunday / Monday / Tuesday
• Team D : Wednesday / Thursday / Friday / Every Other Saturday, Night : 6 : 00 PM 6 : 00 AM
• 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.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources.

Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability.

As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account.

In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly

Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you.

Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals it’s the way we think job searching should be.

Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity.

It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world.

Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities.

At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center.

Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.