Investigations Lead

Zohorecruit; Northern (KY); On-site; USD 90,000 - 130,000; Full time

Job summary

Zohorecruit is 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.

Requirements include a Bachelor’s degree in Science, Pharmacy, and/or Engineering, five years in a parenteral

Qualifications

• Bachelor's degree in Science, Pharmacy, or Engineering.
• Five years in a parenteral manufacturing facility.
• At least one 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 regulatory standards.
• Proficiency with Word, Excel, and PowerPoint.
• Excellent interpersonal and teamwork skills.
• Bilingual in Spanish and English.

Responsibilities

• Ensure QE, NTRs, and NOEs are completed and closed within the established timeframe.
• Review and provide input to regulatory submissions for the area of responsibility.
• Lead QE and CAPA trend evaluations.
• Participate in regulatory inspections when necessary.
• Support site initiatives and other assignments.

Skills

Technical writing

Presentation skills

Statistical data interpretation

Bilingual English/Spanish

Interpersonal skills

Teamwork

Education

Bachelor's degree in Science/Pharmacy/Engineering

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

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.