QA Associate

Kelly Science & Clinical is seeking a QA Associate near West Chester, OH. Contract position (~6 months) Shift: 6pm-6am rotating 12 hour shifts (2-2-3 rotating schedule) Compensation: $25-$29/hr DOE Position Summary The Associate-II Quality Assurance role is integral to ensuring quality standards in both the Process Execution Teams (PET) and designated areas outside of PETs. This role involves supporting various QA activities such as batch release, change control, process validation, deviation investigations, SOPs, supplier management, distribution center management, and regulatory interactions. Initial focus may be on certain specialized areas, with the aim of gaining comprehensive knowledge over time and enhancing proficiency in all responsibilities. Key Responsibilities Develop and maintain a strong understanding of relevant production processes and quality systems. Review and approve GMP documentation impacting operational activities and facilities, including: Change Requests Batch Records and associated documentation Product and Component Release transactions in SAP Quality Investigations (Deviations, Product Complaints) Support Aseptic Manufacturing operations Validation Plans, Protocols, and Reports Standard Operating Procedures Collaborate with and influence quality professionals to ensure consistent execution of quality systems throughout the organization. Execute QA processes, including batch record review, product disposition, and quality issue resolution, to facilitate timely flow of products and documents. Liaise with site support groups on projects impacting the PET/assigned area, ensuring GMP compliance during all project phases. Drive process improvements and risk assessments; benchmark QA practices to identify innovative, efficient, and effective methods. Stay updated on regulatory compliance practices and recommend implementation strategies. Collaborate in data analysis and reporting on quality metrics and key performance indicators. Work Schedule Night Shift: 6 PM – 6 AM Rotational: 2 days on, 2 days off, 3 days on, 3 days off Minimum Qualifications Experience in the pharmaceutical industry, operations, or Quality Assurance. Strong oral and written communication skills. High motivation to learn and develop skills. Aseptic Gown Qualification required Preferred Qualifications Bachelor's degree; Master's degree in science is desirable. Experience in a Lean, process-centric environment with a focus on continuous improvement. Multi-site or multi-functional experience. 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 is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly 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.