Quality Assurance Specialist (batch release) Job Listing at Kelly Services in Irvine, CA (Job ID 10089227)

Description

Title: Quality Assurance Specialist (batch release)
Duration: 8-10 months
Rate: $35/hr.
 
RESPONSIBILITIES:

• Comply with cGMP regulations and all standard operating procedures. 
• Assist in ensuring all personnel comply with cGMP regulations and follow all standard operating procedures. Provide cGMP guidance as needed.
• Coordinate and organize internal training program to ensure personnel performing GMP activities are trained per internal SOP.
• Perform timely review of GMP records (Batch Records, Laboratory Records, Notebooks, etc). Work closely with QA management to proactively address the quality of documentation. Review and release components, raw materials, and finished products.
• Create, revise and/or review SOPs, protocols, reports, change controls and other GMP documentation.
• Conduct and/or review complaint, non-conformance, and deviation investigations.
• Support and organize stability studies for finished product.  
• Provide assistance in preparation and during internal, customer and agency audits.
• Maintain assigned Quality Systems or processes as assigned. Perform tracking and presenting of quality metrics (KPIs). Work with QA management on continuous improvement of the Quality Systems to ensure compliance with regulatory guidelines.
• Use of electronic QMS and other software as required.
• Other related duties as assigned.

 
QUALIFICATIONS:

• Bachelor's degree in a scientific discipline or equivalent (4 years' experience) in a quality control or quality assurance function associated with manufacturing.
• 2+ years' experience in quality control or quality assurance function associated with manufacturing preferred.
• Experience and knowledge of cGMP regulations (21 CFR 210/211) preferred.
• Ability to read and interpret technical procedures, SOP's, GMP's and governmental regulations.
• Strong communication skills, both written and verbal. Ability to multi-task and prioritize tasks as needed.
• Proficient in Microsoft Word, Excel, and PowerPoint.

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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