Quality Control Scientist, Laboratory Chemist

Validation & Engineering Group; Juncos (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading engineering firm in Puerto Rico is seeking a Quality Control Scientist to provide technical expertise in laboratory testing and compliance. The role involves managing programs, generating reports, and ensuring adherence to quality standards. Candidates should possess a Doctorate in Sciences or equivalent experience, be bilingual in English and Spanish, and have strong technical writing and project management skills. This full-time position is essential for maintaining high-quality standards in the pharmaceutical and biotechnological fields.

Qualifications

• Expertise in technical writing with a focus on investigations and validations.
• Experience in Root Cause Analysis and CAPA implementation.
• Strong troubleshooting and problem-solving skills.

Responsibilities

• Function as the technical specialist for testing and development.
• Generate reports and perform data analysis.
• Ensure lab compliance and troubleshoot assays.
• Manage and develop new programs and methodologies.
• Represent the organization on various teams.

Skills

Technical writing

Project management

Data analysis

Bilingual English/Spanish

GMP knowledge

Education

Doctorate degree in Sciences

Master’s degree in Sciences with 3 years experience

Bachelor’s degree in Sciences with 5 years experience

Tools

TrackWise

CDOCS

Maximo

PowerPoint

Excel

Word

OneNote

Job description

Overview

Quality Control Scientist, Laboratory Chemist – Full-time. Validation & Engineering Group (V&EG) provides services for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in laboratory, compliance, computer, engineering, project management, validation, and related services.

Responsibilities

• Under general direction, function as the technical specialist for testing and development in molecular biology and microbiology. Focus is on complex technical issues with multi‑organizational and/or multi‑site scope, including involvement of outside resources.
• Provide technical guidance, generate reports, perform data analysis, and ensure effective communication between technical groups, including follow‑up and issue resolution.
• Troubleshoot assays, resolve technical issues, and ensure lab compliance by implementing procedures that enhance GMP, GLP, and safety.
• Manage existing programs and/or develop and implement new programs, processes, and methodologies.
• Develop, revise, and audit complex controlled documents with potential multi‑organizational and multi‑site impact.
• Approve lab investigations and lead audit teams; may serve as subject matter expert for technical training.
• Represent the department/organization on various teams and independently follow through on multi‑site action items.
• May interact with regulatory agencies regarding areas of responsibility, including written responses, and may resolve issues with outside resources.
• Perform special projects as requested by supervisor and may supervise employees to meet technical requirements.

Competencies & Skills

• Understand, support, and demonstrate values with excellent communication, facilitation, and presentation skills.
• Strong technical writing skills; proficient computer skills (word processing, presentation, databases, spreadsheets).
• Excellent project management and organizational abilities, including independently understanding and following complex instructions to completion.
• Ability to manage multiple responsibilities and shift priorities; extensive knowledge of quality analytical lab processes, validation, manufacturing, quality assurance, process development, and distribution.
• Extensive knowledge of testing, assay development and validation, and pharmaceutical/biological product testing regulations.
• Knowledge of GMPs/CFRs, evaluating compliance issues, and documenting per Company guidelines.
• Proficiency in equipment maintenance, troubleshooting, and operation; advanced data analysis, interpretation, and problem‑solving skills; ability to work independently and interact with various levels, including regulatory agencies.
• Initiate, coordinate, and lead cross‑functional teams; strong leadership, motivation, influence, and negotiation abilities.

Technical Expertise & Qualifications

• Expertise in technical writing with experience generating investigations and method transfers/validations.
• Root Cause Analysis experience with CAPA identification and implementation.
• Fully bilingual English/Spanish.
• Facilitation of meetings and conference calls for multilevel audiences; strong presentation skills.
• Problem solving, troubleshooting, technical proficiency, and basic statistical assessment abilities.

Education & Experience

• Doctorate degree in Sciences or Master’s degree in Sciences with 3 years of directly related experience, or Bachelor’s degree in Sciences with 5 years of directly related experience.
• BS in Chemistry or Biochemistry preferred.
• Knowledge of TrackWise, CDOCS, Maximo; proficiency in PowerPoint, Excel, Word, and OneNote.

Location

Positions available for Puerto Rico.

Equal Employment Opportunity

Validation and Engineering Group, Inc. is an Equal Employment Opportunity employer.