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Quality Facilities Specialist- Compliance

(GMP | Sterile Manufacturing | Deviation Investigations)

**Location:** Parsippany NJ

Do you thrive in GMP-regulated environments and have a knack for investigating complex facility or equipment issues? If so, **we want to hear from you!**

About the Role:

We’re on the lookout for an experienced **Quality Specialist** to join our dynamic Quality & Compliance team. You’ll be front and center, driving critical **deviation investigations** for a fast-paced pharmaceutical manufacturing site. From lyophilizers to filling lines, from humidity control to WFI systems—your expertise will help maintain the highest operational and regulatory standards.

What You’ll Do:

+ Lead and own full-cycle **deviation investigations** from initiation through final resolution and closure.

+ Write clear, concise, and technically sound deviations related to engineering, facilities, and equipment—including sterile manufacturing equipment such as **lyophilizers, vial washers, filling lines, and HVAC systems** .

+ Troubleshoot and collaborate with cross-functional teams across **QC, Microbiology, Supply Chain, Facilities, and Engineering** to identify root causes and corrective actions.

+ Ensure compliance with cGMP, FDA regulations, and internal SOPs.

+ Manage records through **TrackWise** and **Oracle EAM** systems, with future transitions to SAP.

+ Contribute to the reduction of overdue deviations—especially recurring facility-related issues like **humidity control** .

+ Provide technical insight into operations involving **sterile filling** , **WFI systems** , and **environmental systems** .

What We’re Looking For:

+ **3+ years** of engineering or compliance experience in a **GMP-regulated facility** (preferably sterile or aseptic manufacturing). Degree in biology or related field

+ Proven experience leading and **completing deviation investigations** —ownership is key.

+ Strong technical understanding of pharmaceutical manufacturing equipment and systems.

+ Familiarity with systems like **TrackWise** , **Oracle EAM** , and/or **SAP** .

+ Ability to thrive in a collaborative, cross-functional, and fast-paced environment.

+ Bonus: Experience with **lyophilization** , **clean utilities** , **humidity systems** , and **sterile fill-finish processes** .

Why You’ll Love It Here:

+ High-impact role with **site-wide visibility**

+ Work across **multiple departments** and equipment types

+ Help shape compliance strategies and **improve facility performance**

+ Be part of a proactive team that values **technical acumen** and **investigative thinking**

Ready to make a difference?

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 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.

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.