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Job Description: Quality Specialist - GMP Technical Writer

Company: Kelly Science

Location: Parsippany, NJ (On-site)

Benefits: Full benefits package, PTO, growth potential, positive team environment

Overview: Kelly Science is partnering with a leading pharmaceutical company in Parsippany, NJ, to find a dedicated Quality Specialist - GMP Technical Writer. This role is pivotal in ensuring compliance with regulatory standards, investigating equipment deviations, and contributing to the enhancement of quality systems within the manufacturing environment.

Responsibilities:

• Conduct thorough investigations into equipment deviations, encompassing malfunctions, calibration issues, and other factors affecting manufacturing processes.

• Investigate facility equipment and process equipment to ensure operational integrity and compliance.

• Develop and maintain technical documentation, including user manuals, standard operating procedures (SOPs), and troubleshooting guides.

• Collaborate cross-functionally to identify root causes of deviations and evaluate their impact on product quality and regulatory compliance.

• Prepare detailed deviation investigation reports, documenting findings, root causes, and proposed Corrective and Preventive Actions (CAPA).

• Ensure deviation investigations and corrective actions align with Good Manufacturing Practice (GMP) guidelines and other regulatory requirements.

• Partner closely with relevant departments to facilitate the timely and successful implementation of CAPA plans.

• Maintain accurate and up-to-date records of deviation investigations, ensuring adherence to company policies and regulatory standards.

Requirements:

• Proven experience in Quality Assurance/Quality Control related to deviation investigation within a GMP environment.

• Strong analytical and problem-solving skills with a demonstrated ability to identify root causes of deviations.

• Proficiency with Trackwise or similar quality management systems highly desired.

• Bachelor’s degree in chemical engineering, Pharmaceutical Sciences, or a related field.

Why Join Us: Join a dynamic team at the forefront of pharmaceutical innovation. This position offers not only the opportunity to make a significant impact in quality management but also provides a supportive environment for professional growth and development. If you are passionate about quality and ready to contribute to shaping the future of pharmaceutical manufacturing, apply now.

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.