QE Investigations Lead - Quality & Compliance

Veg Group; Manatí (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks a qualified professional to provide operational and scientific expertise in support of Manufacturing Sterile and Non-Sterile Operations.

The contractor will execute manufacturing investigations (QEs) and coordinate information to support those investigations. Requirements include a Bachelor's degree in Science, Pharmacy, or Engineering; 5 years in parenteral manufacturing; 1+ year in investigations; strong technical writing and presentation skills;

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

Regulatory knowledge (cGMPs/OSHA/EPA)

Bilingual Spanish/English

Interpersonal skills

Teamwork

Education

Bachelor's degree in Science, Pharmacy, or Engineering

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

Validation & Engineering Group, Inc. seeks a qualified professional to provide operational and scientific expertise in support of Manufacturing Sterile and Non-Sterile Operations.

The contractor will execute manufacturing investigations (QEs) and coordinate information to support those investigations. Requirements include a Bachelor's degree in Science, Pharmacy, or Engineering; 5 years in parenteral manufacturing; 1+ year in investigations; strong technical writing and presentation skills;