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

• 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.

• 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 statisticaldata.
• Knowledge of cGMPs, OSHA, EPA, and other regulatory standards.
• Proficiency with Microsoft Word, Excel, and PowerPoint.
• Excellent interpersonal skills and ateamwork-oriented approach.
• Excellent written and verbal communication skills in Spanish and English.