Quality (QMS) Administrator - Doc Control (FDA)

PLEASE NOTE : Must be authorized to work lawfully in the United States for any employer without sponsorship. For immediate consideration, please apply.

Kelly® Science & Clinical is seeking a Quality Administrator for a temp-to-hire at a leading client in Orange, 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 :

$30-35.00 / Hour (commensurate with experience)

Overview :

The Quality Administrator will be responsible for developing, executing, and maintaining our client’s Quality Management System.

You will work with a team of administrators to sustain FDA compliance by creating, reviewing, and processing documentation.

Candidate must have strong leadership and communication skills and have the ability to tackle problems as they arise. The Quality Administrator works cross-functionally with internal departments and external resources on the various projects associated with the QMS : FSVP (117) Foreign Supplier Verification Program, Audits, Document Control, FDA Compliance, HACCP program, Equipment Calibration, training records and all other documentation related to the QMS.

Work in harmony with the team to manage the Quality GMP New hire training. Support quality improvement projects such as SOP harmonization, complaints, and corrective action plans.

Schedule :

Day : Monday Friday, Standard Hours

Responsibilities :

• 3-Year SOP / Forms Review, Revise, Create Forms and SOP, Maintain SOP Logs, and tracking of SOPs due for revision.
• Annual Customer Requalification Audits : Complete Supplier Self-Assessment questionnaires and provide requested documentation or prep for on-site audits if requested.
• Support 3rd party audit readiness, i.e. : FDA, UL, NSF, and others to ensure compliance
• CAPA / Complaints Review, Process, and initiate. Maintain associated excel spreadsheets.
• Support Internal Clients by providing documentation re : 3rd party audits / certificates.
• Perform Quarterly internal Audits : for adherence to policies / SOPs / regulations.
• Training : New Hire Onboarding (schedule, train, document, scan, update employee training records).
• Work with Internal clients to Create training curriculums and tests associated with the curriculum. Ensure all training
• records are available for review during 3rd party audits.
• Maintain Equipment use and cleaning and use logbooks.
• Report monthly KPIs assigned to by supervisor / manager.
• Record Retention via external documentation storage.

Qualifications :

• Required High School Diploma, Degree or equivalent.
• 1-3 years in Quality Document Control FDA regulated industry.

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.

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