Investigations Lead

Manati, Puerto Rico | Posted on 10/08/2026

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 manufacturinginvestigations (Quality Events , or QEs) and facilitate the collection andcoordination of information required to support those investigations.

Responsibilities

• Ensure that all QEs, NTRs, and NOEs arecompleted and closed within the established timeframe, using the appropriatetools to prevent recurrence.
• Review and provide input to regulatorysubmissions applicable to the area of responsibility.
• Lead QE and CAPA trend evaluations .
• Participate in regulatory inspections whennecessary.
• Support site initiatives and other assignmentsbased on business needs.
  

Requirements

• Bachelor's degree in Science, Pharmacy, and/orEngineering.
  
• Five (5) years of experience in a parenteralmanufacturing facility .
  
• At least one (1) year of experience in the investigation process .
  
• Strong technical writing and presentationskills.
  
• Ability to interpret and analyze statisticaldata.
  
• Knowledge of cGMPs, OSHA, EPA, and otherregulatory standards.
  
• Proficiency with Microsoft Word, Excel, andPowerPoint.
  
• Excellent interpersonal skills and ateamwork-oriented approach.
  
• Excellent written and verbal communicationskills in Spanish and English.