QA/IT Specialist - STL MO

Quality Assurance/Information Technology Specialist - STL MO

Kelly Science and Clinical is currently recruiting for a qualified, full-time, temporary to potential permanent Quality Assurance(QA)/Information Technology (IT) specialist role. The position is in St. Louis, MO, and the need to fill this position is immediate.

Responsibilities:

• Supporting GxP, QMS (Quality Management Systems), SDLC (Software Development Lifecycle) and Regulated IT system/software validation, overseeing compliance and quality management for IT systems/software.

• Performing the QA role for IT system validation projects including guidance for SDLC strategies, reviewing validation documentation, and review of testing and testing defects.

• Supporting the QA team's efforts for IT system change controls including reviewing change documentation and testing.

• Supporting, certification efforts for the established quality systems in compliance with all appropriate regulations and standards as they relate to IT, including FDA, ISO, HIPAA and GDPR, as applicable.

• Uploading documents into the company's QA management system for review and approvals.

• Providing IT governance document input and review.

• Providing audit support including creation of audit reports and responses to audits for:

• Internal IT Process Audits

• Vendor Qualifications

• External Inspections/Audit Support

• IT assessment support for potential partnerships and clients

• Providing general IT QA guidance and support.

• Assisting with CAPAs and deviations.

Qualifications/Education/Skills:

• Bachelor's degree required, preferably in a life science discipline or equivalent.

• Experience with testing management systems (MicroFocus Application Lifecycle Management (ALM) preferable) within a life science setting.

• 3+ years of IT QA experience with regards to IT validation and FDA regulations

• Highly desirable skill includes IT QA experience within a medical device company

• IT security and data privacy experience

• Experience working in regulated environments (such as GxP, ISO, HIPAA)

Pay: $35 - 40/hr

Hours: Mon - Fri, 8A - 5P - this position will likely be remote

For more information or consideration, please contact me directly at ~~~ or at ~~~!

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.

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.