GMP Lab Scientist II - Innovate in Quality & Compliance

Validation & Engineering Group, Inc.; Barceloneta (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

Validation & Engineering Group, Inc. in Puerto Rico seeks a Scientist II to perform GMP laboratory testing across raw materials, in-process, finished product, stability, and validation.

Requires science degree with multi-year experience and bilingual English/Spanish; strong analytical skills; MS Windows/Microsoft Office proficiency; and solid knowledge of cGxP regulatory guidance. Extended hours may be required.

Qualifications

• Bachelor’s degree in Science (Microbiology, Biology, Chemistry or Bio-Chemistry) with 6 years of related field experience.
• Master’s degree in Science (same fields) with 4 years of related field experience.
• PhD in Science (same fields) with 2 years of related field experience.
• Fully bilingual English/Spanish with excellent oral skills.
• Strong analytical skills and logical thought process.
• Proficient with cGxP and regulatory guidance for compliance.

Responsibilities

• Maintains GMP-compliant laboratory records, procedures and systems.
• Proposes changes to maintain procedural requirements and improve techniques.
• Performs analytical test methods to support product/material release with minimal error.
• Troubleshoots and resolves analytical instrument issues.
• Interprets experimental data for conformance with specifications.
• Initiates appropriate exception documents as required.
• Implements improvement ideas to support team objectives.

Skills

Bilingual English/Spanish

Analytical skills

MS Windows & MS Office

Technical Writing

Regulatory compliance (cGxP)

Extended hours availability

Education

Bachelor’s degree in Science

Master’s degree in Science

PhD in Science

Tools

MS Windows

Microsoft Office

Job description

Validation & Engineering Group, Inc. in Puerto Rico seeks a Scientist II to perform GMP laboratory testing across raw materials, in-process, finished product, stability, and validation.

Requires science degree with multi-year experience and bilingual English/Spanish; strong analytical skills; MS Windows/Microsoft Office proficiency; and solid knowledge of cGxP regulatory guidance. Extended hours may be required.