Senior Specialist, Technical Quality (IDAP)

Kelly Science is seeking a Senior Specialist, Technical Quality for a growing company located in West Chester, OH.

Pay: $45/hour

Shift: Monday-Friday 1st Shift

Employment Type: Full Time; Temp-to-Hire

Summary:

As the Senior Specialist, Technical Quality, you will be responsible for providing QA oversight for Sterile Operations and assigned areas, ensuring GMP compliance and timely product and document flow. Supporting batch disposition, quality systems, validation, investigations, change control, supplier and distribution activities, and regulatory interactions.

Job Responsibilities:

• Provide QA oversight for assigned production areas, maintaining expertise in manufacturing processes, sterile operations, technology, and applicable GMP quality systems.

• Review and approve GMP documentation, including change requests, batch records, SAP release transactions, investigations, validation documents, and SOPs; own batch disposition processes and release or reject incoming materials and product.

• Lead QA execution and resolution of quality issues, ensuring timely product disposition and document flow while meeting site objectives and key performance metrics.

• Advise and partner with Operations, QC, Supply Chain, project teams, and other Quality groups on quality systems, risk assessments, process improvements, and GMP compliance throughout project planning, execution, and closeout.

• Serve as process owner or subject matter expert for assigned processes; analyze quality metrics, monitor performance, and recommend effective practices and strategies in response to evolving regulatory expectations.

• Demonstrate independent leadership by influencing teams, holding stakeholders accountable, and training, mentoring, and coaching QA and non-QA colleagues.

Qualifications:

• Bachelor's degree in a scientific related field

• 5+ years of experience working within a pharmaceutical industry with significant experience in sterile/aseptic manufacturing working within an operations environment and/or quality assurance.

• Experience supporting quality investigations, change requests, product and components rereleases, etc.

• Demonstrated knowledge of GMP requirements, Quality Systems and the pharmaceutical supply chain environment

Interested? Please apply today for immediate consideration!

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. 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.

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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.