QA Validation Coordinator

3 weeks ago

Columbus, United States Kelly Services, Inc. Full time
Kelly Scientific is searching for a skilled QA Validation Coordinator to support a biopharma customer advancing novel gene therapies from concept to commercialization. Located in the heart of Columbus, OH and 100% onsite.

Job Title: Quality Assurance Validation Coordinator
Location: Columbus, OH
Rate: $35/hr.
Shift: 8am-4:30pm | Mon-Fri
Length of Assignment: 6 months

The Quality Assurance Specialist Validation Coordinator is responsible for managing validations related to manufacturing product, process, equipment, laboratory and facility, contributing to the oversight of key strategic, tactical, and operational aspects within Quality Assurance.

In this critical QA role, you will lead as a Subject Matter Expert in a newly formed quality assurance team with a primary focus on Phase 3.
 
  • Review/Manage equipment, process, and test method validations and Quality review and approval associated activities for a newly constructed cell and gene therapy CDMO facility.
  • Support Regulatory Agency submissions and audits by being a Subject Matter Expert in the assigned area.
  • Review and audit complex documents: batch records, GMP protocols, process and method validations in compliance with QMS, policies, and procedures.
  • Observe manufacturing activities to support the implementation of best practices and improvements, including the transfer of site knowledge to new facility startup activities.
  • Support technology transfer initiatives, as assigned.
  • Manage QMS; author, review, and approve SOPs and Policies for the new facility.
  • Prepare routine updates and project status reports of Quality Assurance activities.
  • Provide oversight and input to Trend Review Reporting and Lifecycle Review activities to identify and address process shifts and trends.
  • Ensure that documentation is maintained in accordance with internal procedures and regulatory requirements.
  • Support, prepare, and provide Quality training with cross-functional teams as assigned.

Requirements:
  • Minimum of 2-3 years experience GMP/Biopharmaceutical/Biotech Industry/FDA
  • QA hands-on experience in a pharmaceutical or cell and gene therapy environment preferred.
  • Bachelor’s Degree in a technical or scientific discipline or equivalent
  • Operational knowledge of cGMP regulations and guidelines including but not limited to U.S. Code of Federal Regulations 21 CFR Part 11 and Part 210 & 211
  • Demonstrated Project Management abilities to lead and manage several projects, meeting deadlines, and use critical thinking skills to problem solve effectively.
  • Excellent verbal and written communication skills at all levels of the organization.
  • Technical writing is required.
  • Experience with FDA, and EMA inspection interaction.
  • Strong experience working in cross-functional teams.
  • Ability to influence, negotiate, manage conflict, and collaborate.
  • Must demonstrate a “can-do” attitude.
  • Proficient using Microsoft applications (Word, Excel, PowerPoint).
  • Knowledge of application software such as Trackwise, and SAP, preferred.

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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