Job Details

  • Title: Regulatory Compliance Associate
  • Code: RCI-22936-1
  • Location: Rocky Mount North Carolina (NC) 27804
  • Posted Date: 09/14/2021
  • Duration: 18 Months
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  Job Description

Remote with some On-Site (candidate will need flexibility)

Key responsibilities:

 

Act as core team member responsible for coordinating and identifying Regulatory and Compliance Remediation activity plans related to product transfer.

 

Basic Qualifications and Skills needed

  • Degree in Science or Engineering based discipline, laboratory experience a plus
  • Familiarity with Change Management requirements, and Processes related to Compendial methods remediation, validation/qualification for manufacturing, and Quality and technical risk management tools.
  • Relevant Drug Product Technical Experience related to processing and manufacturing pharmaceutical products.
  • Excellent Communication and presentation skills.
  • Relevant experience with manufacturing operations for Sterile Injectable Drug Products.
  • Relevant skills to gathering data from multiple sources and summarizing into simple, well organized documents
  • Ability to be flexible and manage multiple deadlines
  • Work independent to meet deadlines within team goals
  • Documentum, Doc-U Sign and Track-wise experience preferred
  • BS Degree is required