Lead QE Investigator & Compliance Specialist

Pinnaql, Inc.; Manatí (PR); Vor Ort; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, seeks a qualified professional to provide operational and scientific expertise with compliance knowledge in support of Manufacturing Sterile and Non-Sterile Operations.

The contractor will execute manufacturing investigations (QEs) and coordinate information needed for those investigations. The role requires a Bachelor's degree in Science, Pharmacy, or Engineering, 5+ years in a parenteral manufacturing facility, and strong

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Technical writing

Analytical skills

Communication

MS Office

Bilingual English/Spanish

Ausbildung

Bachelor's degree in Science/Pharmacy/Engineering

Jobbeschreibung

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, seeks a qualified professional to provide operational and scientific expertise with compliance knowledge in support of Manufacturing Sterile and Non-Sterile Operations.

The contractor will execute manufacturing investigations (QEs) and coordinate information needed for those investigations. The role requires a Bachelor's degree in Science, Pharmacy, or Engineering, 5+ years in a parenteral manufacturing facility, and strong