Overnight Quality Assurance Specialist Job Listing at Kelly Services in Springfield Township, NJ (Job ID 9579048)

Description

Kelly Science is seeking an Overnight QA Specialist for a growing company located in Springfield, NJ.

Shift: Wednesday-Sunday 9pm-8am (1 hour)
Employment Type: Full Time; Direct Hire

Job Duties:

• Responsible for disposition of incoming production materials and release activities for site manufactured drug products.
• Author documents and standard operating procedures, review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
• Identify potential risks before they become a problem, focusing on root cause analysis and preventive action.
• Perform internal and external quality audits and compile detailed reports of findings.
• Provide training and support to quality and production teams on systems, policies, procedures, and core processes.
• Analyze and investigate product complaints or reported quality issues to ensure closure in accordance with company guidelines and external regulatory requirements.
• Maintain company complaint and inspection procedures to ensure capture and investigation, as well as proper documentation of complaints.
• Identify and escalate non-conformances to site procedures, properly document and investigate Quality Events as per site SOPs and FDA guidance documents.
• Participate in and support both client and regulatory audits.
• Participate in CAPA teams, planning and implementation of continuous improvement initiatives
• Support daily QA activities such as document and batch record review when needed

Qualifications

• Bachelor's Degree in a scientific field.
• 3-5 years of experience in the pharmaceutical industry. Radiopharmaceutical experience preferred.
• Understanding of FDA, and other applicable regulatory requirements for finished pharmaceuticals.
• Strong technical writing and oral communication abilities.
• Experience working with electronic quality management and laboratory information management systems.

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. 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 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 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.

 Apply on company website