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Manufacturing Support Associate

  1. North America, East Coast
North Carolina
  1. Contract
Competitive
  1. Compliance / Quality Assurance
37277
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Manufacturing Support Associate - US, North Carolina - 4 Month Contract (temp to perm)

Our client, a global pharmaceutical manufacturing organization are looking for a talented Manufacturing Support Associate 3, to join their expanding team. With continued organizational growth and considerable investment across their portfolio and capital programs this is an extremely exciting opportunity to contribute towards their brand-new manufacturing facility on the East Coast of the United States.

Essential Duties and Responsibilities for this role include, but are not limited to:
  • Collaborates with stakeholders to implement compliance initiatives and carry out regulatory assessments, ensuring full alignment with industry standards and organizational goals
  • Promotes a robust organizational structure by effectively overseeing CAPA execution and compliance monitoring to maintain high performance standards, while developing and implementing risk mitigation strategies
  • Provides expert guidance on regulatory changes and industry trends
  • Serves as a liaison between regulatory bodies and internal teams
  • Collaborates effectively with cross-functional stakeholders to coordinate and execute comprehensive Annual Product Reviews, ensuring alignment with regulatory requirements and promoting continuous improvement in product quality and process efficiency
  • Supports reliable production during regular operations
  • Leads troubleshooting as a process subject matter expert (SME)
  • Coordinates Batch Planning including process template creation and import and management of preventive maintenance plans (PMs)
Requirements:
  • Understands cGMP regulations and industry guidelines from health authorities (e.g., Federal Drug
  • Administration (FDA), European Union Medicines (EMA), Medicines and Health-care products Regulatory
  • Agency (MHRA), and other health authorities
  • Understands aseptic processing principles, including (e.g., gowning, contamination control, and cleanroom behavior)
  • Familiar with isolator technology, automated filling lines, and visual inspection processes
  • Adapts to changing regulatory requirements and implements new training approaches accordingly
  • Uses problem-solving and critical-thinking skills to address training gaps and improve processes
  • Strong analytical and problem-solving skills
  • Expertise in quality and risk management
If you are interested, please apply now for immediate consideration and further information.
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