Associate Quality Specialist Job Listing at Kelly Services in Morrisville, NC (Job ID US3538839_BH9337271)

Description

Associate Quality Specialist
Monday-Friday first shift with overtime expected (10-12 hour days)
Location: Morrisville NC
Hourly Pay Rate: $26-$40 depending on experience
Temp to hire contract role for 3-6 months-before converting to full time

Position Overview:
The Associate Quality Specialist will be responsible for leading, supporting, and ensuring the continued suitability of the Quality Management System (QMS). This role focuses on quality systems management in areas such as design control, validation, risk management, supplier management, process control, post-market surveillance, complaint handling, CAPA (Corrective and Preventive Actions), auditing, change control, document control, and training.

Key Responsibilities:

• Ensure compliance of the Quality System with both domestic and international regulations.
• Promote quality awareness and provide training across the organization on best practices, quality principles, and tools.
• Support the implementation of corporate policies and procedures related to quality, design control, risk management, process development, and regulatory compliance (e.g., FDA/ISO).
• Collaborate with cross-functional teams to address product and process quality issues and implement continuous improvement initiatives.
• Coordinate inspections and testing of raw materials, work-in-process, finished goods, and environmental conditions.
• Design, develop, and maintain forms, instructions, and procedures for recording, evaluating, and reporting quality and reliability data.
• Write, coordinate, and support the Corrective/Preventive Action (CAPA), deviation, and change control systems.
• Support the document control and training systems to ensure compliance with company standards.
• Investigate, report, and resolve customer complaints.
• Conduct supplier audits and collaborate with suppliers to address corrective actions and requests for corrective actions.
• Coordinate and support the annual audit program; schedule, perform, and report on internal, external, and supplier audits.
• Compile and report quality metrics and post-market surveillance data in line with regulatory requirements.

Requirements:

• Education:

  • Bachelor's Degree in Biology, Chemistry, Life Sciences, or Engineering with at least one year of experience in a quality role supporting clinical research, pharmaceutical development, or IVD development; OR
  • Associate's Degree in Biology, Chemistry, Life Sciences, or Engineering with at least three years of relevant experience in a quality role.

• Skills and Qualifications:

  • Thorough understanding of quality management principles, systems, tools, and standards.
  • Strong communication and writing skills.
  • Excellent organizational skills with the ability to manage multiple projects simultaneously.
  • Ability to manage workload independently and meet deadlines.

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.

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