Quality Investigations Lead – QE & CAPA Expert

Zohorecruit; Manatí (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Zohorecruit in Manatí, Puerto Rico seeks an Investigation Lead to provide operational and scientific expertise, plus regulatory knowledge, in support of manufacturing sterile and non-sterile operations. The role focuses on executing manufacturing investigations and coordinating information for Quality Events (QEs).

You will ensure timely completion of QEs, NTRs, and NOEs, review regulatory submissions, lead QE and CAPA trend evaluations, participate in regulatory inspections, and support site

Qualifications

• 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.

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.

Skills

Technical writing

Presentation skills

Statistical data interpretation

Interpersonal skills

Bilingual English/Spanish

Education

Bachelor's degree in Science/Pharmacy/Engineering

5 years parenteral manufacturing experience

Tools

Microsoft Word

Excel

PowerPoint

Job description

Zohorecruit in Manatí, Puerto Rico seeks an Investigation Lead to provide operational and scientific expertise, plus regulatory knowledge, in support of manufacturing sterile and non-sterile operations. The role focuses on executing manufacturing investigations and coordinating information for Quality Events (QEs).

You will ensure timely completion of QEs, NTRs, and NOEs, review regulatory submissions, lead QE and CAPA trend evaluations, participate in regulatory inspections, and support site