Quality Assurance Specialist – Louisville, CO

　　Type: Contract (6 months, potential for extension)

　　Shift: M-F 8a-5p

　　Pay Rate: $30-$37/hr

　　POSITION SUMMARY

　　This position will focus on supporting the Good “X” Practices (GxP) Vendor Management program with a potential to support other QA functions as needed.

　　REQUIREMENTS

　　Works effectively cross-functionally across to fulfill Vendor QA oversight responsibilities.

　　Supports the GMP supplier notification and change process, working with cross-functional subject matter experts (SMEs) to assess and document impact.

　　Supports the Supplier Corrective Action Record (SCAR) process and material defect management process.

　　Supports vendor recertification events for identified vendors in collaboration with cross-functional SME.

　　Provide administrative support for the Vendor Management program, as needed.

　　Executes controlled document archival process, when required.

　　May review and approve Standard Operating Procedures (SOPs) and other controlled documents

　　Provides additional support within the Quality organization, as needed

　　Potential to support organizations outside of Quality, if needed, to accomplish facility startup objectives and routine operations.

　　Other duties, as assigned

　　The successful candidate will have:

　　Bachelor’s degree in Biochemistry, Molecular and Cellular Biology, Immunology, Biology, or other life science with 0-5 years of work experience in an FDA regulated industry, or similar combination of education and experience

　　An understanding of quality management systems and vendor management.

　　Knowledge of relevant pharmaceutical regulations and regulatory guidance.

　　Strong communication and organizational skills and a passion for teamwork.

　　Ability to work effectively and efficiently in a collaborative manner across multiple functional areas and vendors.

　　Preferred Qualifications:

　　Previous experience with a vendor management program in a current Good Manufacturing Practice (cGMP) environment.

　　Previous experience in a Quality organization supporting a cGMP biopharmaceutical manufacturing facility startup and/or operations environment.

　　Experience in cGMP cell and gene therapy manufacturing and/or testing facility.

　　Physical Requirements:

　　Ability to gown aseptically and work in a Clean Room environment, if required

　　Ability to stand for extended periods of time to fulfill on-the-floor Quality duties, if required

　　Must have the ability to work around laboratories, manufacturing areas and equipment, and regularly lift 10-20 lbs. and periodically lift up to 50 lbs.

　　Ability to primarily work onsite, working remotely when appropriate.

　　#P1

　　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 (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) 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 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.