Senior QE Investigator—Manufacturing & CAPA (Bilingual)

Veg Group; Northern (KY); On-site; USD 85,000 - 125,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks a talented professional to provide operational and scientific expertise for manufacturing QA investigations (QEs) in sterile and non-sterile operations.

You will coordinate information and ensure timely closure of QEs, NTRs, and NOEs while supporting regulatory submissions and CAPA trend analyses. The role requires a Bachelor's in Science, Pharmacy, or Engineering with 5 years in a parenteral facility, plus at least 1 year in investigations.

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

Data analysis

Teamwork

Bilingual English/Spanish

Education

Bachelor's degree in Science, Pharmacy, or Engineering

Tools

MS Word

MS Excel

PowerPoint

Job description

Validation & Engineering Group, Inc. seeks a talented professional to provide operational and scientific expertise for manufacturing QA investigations (QEs) in sterile and non-sterile operations.

You will coordinate information and ensure timely closure of QEs, NTRs, and NOEs while supporting regulatory submissions and CAPA trend analyses. The role requires a Bachelor's in Science, Pharmacy, or Engineering with 5 years in a parenteral facility, plus at least 1 year in investigations.