Regulatory Compliance Specialist

4 weeks ago

Washington, Washington, D.C., United States Adecco Full time

The Regulatory Compliance Specialist will be responsible for ensuring that all manufacturing processes meet FDA and regulatory requirements. This includes developing and executing protocols for equipment, processes, and products. The ideal candidate will have 1-2 years of experience in packaging, equipment validation, or engineering technical writing, and a strong emphasis in a natural science or engineering. They must have excellent communication skills, be able to read and analyze business information, and have a strong understanding of regulatory and GMP requirements.

Key Responsibilities

  • Develop and execute installation, operation, and performance qualification protocols and summary reports.
  • Develop and execute product validation protocols.
  • Develop and execute cleaning validations.
  • Perform training and write Standard Operating Procedures (SOP's) / Work Instructions.
  • Interface with customers and maintain good documentation practices.
  • Communicate effectively with cross-functional groups to meet compliance requirements and release goals.
  • Assist in the maintenance of the Validation Master Plan (VMP) and Cleaning Validation Master Plan (CVMP) schedules.

Requirements

  • Associate or bachelor's degree with a strong emphasis in a natural science or engineering.
  • Excellent communication skills, including written and verbal communication.
  • Strong project management skills and ability to read, analyze, and interpret business information.
  • Familiarity with regulatory and GMP requirements for pharmaceutical manufacturing operations.
  • PC proficiency in Microsoft Office, Google Suite, and statistical analysis software.

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