Kelly Science and Clinical is searching for a skilled QA professional with experience in deviation resolution to support an established biopharma manufacturer in Indianapolis. This is a 1-year contract role focused on reducing non-terminal records beyond their due date, backlogs and reduction of deviation cycle time.

　　Title: Quality Assurance Representative - Contractor

　　Location : Indianapolis, IN metro area (3 days onsite per week)

　　Start Date : ASAP

　　Length : 1 year contract

　　Hourly Rate : Negotiable/Commensurate with Experience

　　Summary:

　　The Quality Assurance Representative - Contractor provides support to key projects or tasks defined to improve management and compliance of suppliers, materials, data, processes and/ or systems.

　　Responsibilities:

　　Execute actions required to complete nonterminal data records and meet metric targets and required due dates.

　　Create and/or revise GMP documents with collaboration of subject matter owners and in compliance to company standards and external regulations.

　　Assist as a lead investigator for quality deviations.

　　Perform materials data management transactions in electronic systems, if necessary.

　　Support maintenance of complaint database (track supplier responses for warehouse, incoming and operations complaints).

　　Minimum Requirements:

　　Demonstrated relevant experience in a GMP facility.

　　Proficiency with current computer systems and applications including Microsoft Office products, SAP, electronic document management systems (EDMS) and TrackWise or similar systems.

　　Strong oral and written communication and interpersonal skills.

　　Ability to influence externally with suppliers and resources across sites.

　　Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.

　　Preferred: Experience with deviation and change control processes.

　　Preferred: Experience in material management, quality systems and cGMPs.

　　Education Requirements:

　　Bachelor’s degree or equivalent experience in a science-related field.Other Information:

　　Overtime may be required.

　　Onsite attendance is required and based on agreement.

　　Applicant may work in various areas within the IDAP Site.

　　Some allergens are present in the IDAP Site.

　　Mobility requirements and exposure to allergens should be considered when applying for this position.

　　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.