Quality Assurance Specialist, Batch Release Job Listing at Kelly Services in Irvine, CA (Job ID 10123890)

Description

Quality Assurance Specialist, Batch Release
 
Kelly® Science & Clinical is seeking a Quality Assurance Specialist, Batch Release for an 8-month contract position at a premier pharma company in Irvine, 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:  
$35/hour

Overview:
This client is a leading CDMO providing services for the entire drug product lifecycle.    
 
The Quality Assurance Specialist, Batch Release ensures adherence to cGMP regulations by reviewing records, releasing products, and conducting internal training while supporting investigations, audits, and continuous improvement of quality systems.

Schedule: 
Monday-Friday, standard working hours
 
Responsibilities:

• Ensure compliance with cGMP regulations and internal standard operating procedures (SOP) across all activities.
• Review GMP records, including batch and laboratory documentation, and coordinate the release of components, raw materials, and finished products.
• Organize and manage internal training programs to keep personnel updated on GMP requirements and practices.
• Create, revise, and review SOPs, protocols, reports, and other GMP-related documentation.
• Participate in and review investigations of complaints, non-conformance, and deviation incidents.
• Support and coordinate stability studies for finished products.
• Assist with preparation and participation in internal, customer, and agency audits.
• Maintain quality systems, track and present quality metrics (KPIs), and collaborate on continuous improvement initiatives using electronic quality management systems.
• Other duties as assigned.

Qualifications:

• Bachelor's degree in Science or related field.
• 2+ years of experience in Quality Assurance in a GMP environment.
• Experience with 21 CFR 210/211 strongly preferred.

 
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 is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly 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.

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