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Company: Kelly Services
Location: Parsippany Troy Hills, NJ
Career Level: Associate
Industries: Recruitment Agency, Staffing, Job Board

Description

QA Specialist -Shop Floor Manufacturing and Packaging Monitoring- Parsippany NJ
Job Overview:
As the Specialist QA, you will be responsible for shop floor monitoring, clearance, and record review during aspects of parenteral manufacturing. This includes, but is not limited to, raw material release, compounding, aseptic filling, lyophilization, inspection, labeling, and packaging. Responsibilities:

  • Monitor production activities for conformance to approved procedures. Identify any deviations or non-conformances during all production activities. Initiate QA-track events as appropriate and monitor investigations for on-time completion.
  • Perform AQL sampling and inspection of raw materials, and inspected, labelled, and finished products according to ANSI/ASQ Z1.4 standards and approved procedures.
  • Perform batch record review for all production steps – ensure compliance to established and validated parameters.
  • Author and/or provide input for new and revised quality procedures.
  • Train on and support Controlled (Grade C and D) and Aseptic (Grade A and B) processing areas with Line Clearances, QA oversight, and batch record review (MBR and EBR).
  • Obtain and maintain gowning training for Grade C and D, and Gown Qualification for Grade A and B.
Requirements:
  • Bachelor's degree in health sciences with a minimum of 2 years of experience in a quality operations role. Alternatively, candidates may be considered with a total of 8 years of equivalent experience in a quality operations role.
  • Previous aseptic gown training preferred.
  • Knowledge of sterile operations preferred.
  • Knowledge of cGMPs.
Physical Requirements:
  • May need to spend extended periods standing or walking to inspect production processes, equipment, and products. The need to bend, stoop, or reach to access equipment or products in different areas of the shop floor is common.
  • May be required to wear PPE, such as safety glasses, gloves, lab coats, or 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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