Description
QA Specialist (Master Control System Administration)
Location: Irvine, CA
Pay Rate: $31/hr DOE
Shift: Monday - Friday 7am to 3:30 pm
Contract Role
Kelly® Science & Clinical is seeking a QA Specialist (Master Control System Administration) to support a pharmaceutical company's Quality Department on a contract basis. This position will cover a leave of absence and is ideal for a candidate with experience in document management systems administration. The role is critical to ensuring compliance with cGMP and maintaining effective quality management systems.
Overview:
The QA Specialist will oversee the Master Control system, ensuring it is configured and maintained to support cGMP compliance and product safety. This role will be instrumental in document control, change management, audit readiness, and risk management activities. The successful candidate will ensure the system is well-maintained, documents are accurately controlled, and changes to processes and documentation are properly managed.
Responsibilities:
- Ensure Master Control system configuration aligns with cGMP requirements.
- Collaborate with the Master Control support team for troubleshooting, project updates, and system enhancements.
- Onboard new employees and facilitate quality system module setup/launch.
- Maintain document control within Master Control, ensuring SOPs, batch records, and quality event reports are properly versioned and accessible.
- Manage the change control process within the Master Control system, ensuring changes are reviewed, approved, and tracked.
- Support audit readiness by ensuring documentation and processes are in compliance with regulatory requirements.
- Provide Key Performance Indicators (KPIs) for change controls and document management activities.
- Contribute to effective risk management practices by ensuring all data is accurately recorded and quality processes are followed.
Qualifications:
- Previous experience as a Master Control System Administrator or in document management systems in a regulated environment (preferably cGMP).
- Strong knowledge of document control processes, including SOPs, batch records, and change controls.
- Familiarity with regulatory requirements (FDA, cGMP) and audit readiness.
- Strong attention to detail and organizational skills.
- Ability to work independently and as part of a team to troubleshoot issues and ensure system functionality.
- Excellent communication skills, both verbal and written.
This contract position is an excellent opportunity to contribute to the pharmaceutical industry's quality systems while working in a dynamic and supportive environment.
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.
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