Investigations Lead

We are seeking an Investigation Lead to provide operational and scientific expertise, together with compliance knowledge, in support of manufacturing sterile and non-sterile operations. The resource will execute manufacturing investigations (Quality Events, or QEs) and facilitate the collection and coordination of information required to support those investigations.

Responsibilities

• Ensure that all QEs, NTRs, and NOEs are completed and closed within the established timeframe, using the appropriate tools to prevent recurrence.
  
• Review and provide input to regulatory submissions applicable to the area of responsibility.
  
• Lead QE and CAPA trend evaluations.
  
• Participate in regulatory inspections when necessary.
  
• Support site initiatives and other assignments based on business needs.
  

Requirements

• Bachelor's degree in Science, Pharmacy, and/or Engineering.
  
• Five (5) years of experience in a parenteral manufacturing facility.
  
• At least one (1) year of experience in the investigation process.
  
• Strong technical writing and presentation skills.
  
• Ability to interpret and analyze statistical data.
  
• Knowledge of cGMPs, OSHA, EPA, and other regulatory standards.
  
• Proficiency with Microsoft Word, Excel, and PowerPoint.
  
• Excellent interpersonal skills and a teamwork-oriented approach.
  
• Excellent written and verbal communication skills in Spanish and English.