Overview
Quality Assurance (QA) Project Support Jobs in Raleigh, NC at Randstad USA
Title: Quality Assurance (QA) Project Support
Company: Randstad USA
Location: Raleigh, NC
Quality Assurance (QA) Project Support – Contract Position
Location: Raleigh, NC (On-Site)
Contract Duration: 6 months (with potential for extension)
Start Date: March 31, 2025
About the Role
Biogen is seeking a Quality Assurance (QA) Project Support professional to assist in the Large-Scale Manufacturing (LSM) Modernization Project. This initiative aims to implement a new Manufacturing Execution System (MES), including electronic equipment tracking, electronic batch records, and release by exception functionalities. The selected candidate will play a key role in ensuring operational readiness and successful integration of the MES system into routine production.
Key Responsibilities
Support operational readiness efforts to prepare for MES implementation.
Assist the QA team with documentation creation, updates, and reviews.
Provide meeting support and contribute to design discussions by offering recommendations for improvements and compliance.
Support batch record traceability mapping and other quality-related assignments as required.
Work directly with the newly implemented MES system and associated documentation.
Ensure adherence to regulatory requirements (FDA, EMA) and GMP standards.
Qualifications & Skills
Education:
Bachelor’s degree in Science, Engineering, or a related technical field.
Experience:
Minimum 5+ years of experience in Quality Assurance (QA) or Quality Operations within the pharmaceutical or biotech industry.
Experience in large molecule, drug substance manufacturing.
Familiarity with MES or electronic batch records (preferred).
Strong knowledge of FDA, EMA, and regulatory compliance requirements.
Experience working within a highly regulated, compliance-driven setting.
Technical & Soft Skills:
Strong analytical, problem-solving, and organizational skills.
Ability to work cross-functionally with various teams.
Proficiency in MS Office; experience with myCIMS or Veeva is a plus.
Excellent communication and interpersonal skills.
Ability to manage multiple tasks in a fast-paced environment.
Work Environment & Schedule
On-site position at Biogen’s Raleigh, NC manufacturing facility.
Standard Monday–Friday work schedule with occasional overtime as needed.
Frequent interaction with project teams, contractors, and site operations staff.
Ability to work in an open office environment with potential distractions.
Why Join Us?
This is an exciting opportunity to contribute to a high-impact modernization project within a leading biopharmaceutical company. If you have a strong background in quality operations, regulatory compliance, and manufacturing execution systems, we encourage you to apply!
Apply today to be part of this transformative initiative!
