Quality Assurance Shop Floor Specialist Job Listing at Kelly Services in Hanover, NJ (Job ID US3548682_BH9775037)

Description

Specialist, Quality Assurance (QA) Shop Floor- Parsippany, NJ
Role Overview:
As a Specialist QA, you will play a key role in ensuring quality and compliance across various stages of parenteral manufacturing, including raw material release, compounding, aseptic filling, lyophilization, inspection, labeling, and packaging. You will ensure strict adherence to approved procedures and regulatory standards, contributing to the production of high-quality products.
Key Responsibilities:

• Monitor production activities for compliance with established procedures and identify deviations or non-conformances.
• Initiate and track quality events and ensure timely resolution of investigations.
• Perform AQL sampling and inspection of raw materials, labeled, and finished products per ANSI/ASQ Z1.4 standards.
• Review batch records to ensure adherence to validated parameters and established protocols. Provide input and authorship for new and updated quality procedures.
• Train and support on controlled (Grade C/D) and aseptic (Grade A/B) processing areas, performing line clearances and batch record reviews.
• Maintain gowning training for Grade C/D and gown qualifications for Grade A/B.

Qualifications:

• Bachelor's degree in health sciences or equivalent; minimum 2 years of experience in quality operations. Alternatively, 8 years of equivalent experience may be considered.
• Preferred experience in aseptic gowning and sterile operations.
• Knowledge of cGMPs and regulatory requirements.
• Strong communication and interpersonal skills, with the ability to collaborate across teams.
• Ability to work extended hours or weekends, as required.

Physical Requirements:

• Extended periods of standing or walking to inspect production processes, equipment, and products.
• Ability to lift moderate to heavy equipment, inspection tools, or product samples.
• Regular bending, stooping, or reaching to access equipment in different areas.
• Use of personal protective equipment (PPE), including gloves, safety glasses, lab coats, and respiratory protection.

 

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.

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