Job Description

If you are you a meticulous and driven Quality Assurance professional looking to make a significant impact, Randstad is looking for qualified professionals to work onsite with their client in RTP. In this position, you will have an opportunity to work in a well-respected Biotechnology company AND have the support you need with a career coach guiding you towards success :)

PLEASE DO NOT APPLY if you live outside the Raleigh-Durham area as this role is 100% onsite.

Who You Are:

• You're an individual with 2+ years of experience within a biopharmaceutical or highly regulated environment.
• You possess a keen eye for detail and a strong commitment to quality.
• You're proactive, eager to learn, and thrive in an environment where your contributions directly support groundbreaking science.

What You'll Do:

• Be a Guardian of Quality: Meticulously review GMP raw data for compliance, ensuring the integrity of our processes and products with your review and approval of batch related documentation ( Solution Lot records, Reports, Logbooks and Release of Autoclaved Equipment) .
• Transport batch related documentation across RTP buildings supporting chain of custody and life cycle management.
• Ensure Compliance Excellence: Support the resolution of technical and compliance issues/gaps .
• Collaborate and Grow: Partner with key Quality and Manufacturing teams, gaining exposure to diverse aspects of biopharmaceutical production and contributing to the day-to-day implementation of cGMP.
• Assist in additional responsibilities related to the day-to-day implementation of the Quality Management Systems required to maintain cGMP compliance, ensuring the safety, efficacy and purity of the products.
• Logistics & Life Cycle Management: Secure transport of critical batch documentation, supporting seamless chain of custody.
• Opportunity to contribute to projects.

Preferred Professional Experience:

• 2-5 years' experience as a QA associate within a large molecule, drug substance facility
• Regulatory requirements in the pharmaceutical industry (FDA, EMA)
• Able to manage multiple tasks in a fast-paced environment

Education:

• Bachelor’s degree in science or other related field of study

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