Specialist Quality Control - 35191

mîrus Consulting Group is a Puerto Rico based technical services firm headquartered in Humacao. The company specializes in Computer System Validation (CSV) and Information Technology consulting for the pharmaceutical and life sciences industries across Puerto Rico and parts of the United States. Its services include the assessment and validation of automation systems, network infrastructures, and business processes, as well as comprehensive project management support to ensure compliance, efficiency, and operational excellence.

Job Summary
The Specialist Quality Control functions as the technical specialist for testing and development in areas of molecular biology and microbiology. Focus is on the complex technical issues and scope is typically multi-organizational and/or multi-site and /or involving outside resources. The Specialist Quality Control is responsible for supporting quality control laboratory operations within a regulated pharmaceutical environment. This role ensures compliance with quality standards, regulatory requirements, and internal procedures through scientific data analysis, method validation and transfer, sample management, and quality process management.

Key Responsibilities

• Perform and support scientific data analysis for Quality Control activities.
• Strong Technical Writing (English and Spanish) mainly focuses.
• Utilize Microsoft Excel as a primary tool for data analysis and trending.
• Support sample management activities including receipt, tracking, testing, and disposition.
• Participate in project management activities related to method validation, method transfer, and quality improvements.
• Support and maintain quality process management, ensuring compliance with GMP and internal procedures.
• Assist with computer system validation and analytical method validation (preferable experience).
• Support equipment preventive maintenance, basic troubleshooting, and documentation.
• Develop inspection, qualification, or validation protocols under short timelines.
• Prioritize critical tasks efficiently in a fast-paced and regulated environment.
• Collaborate cross-functionally and communicate effectively with internal stakeholders.
• Demonstrate strong negotiation and problem-solving skills when dealing with quality issues.

Minimum Requirements
One of the following combinations is required:

• Doctorate degree in a scientific field or
• Master’s degree with a minimum of 2 years of directly related experience or
• Bachelor’s degree with a minimum of 4 years of directly related experience
• Field of Study
  • Scientific background in Science or Engineering
• Experience in the Pharmaceutical Industry, preferably within Quality Control laboratories
• Background or experience as Microbiologist, Chemist, Biochemist, Molecular Scientist, or Chemical Engineer
• Experience with laboratory testing, method validation, method transfer, and quality processes

Required Skills and Competencies

• Strong technical writing skills (English/Spanish)
• Excellent communication and interpersonal skills
• Strong organizational and time management skills
• Ability to manage multiple priorities and meet deadlines
• High attention to detail and commitment to quality and compliance
• Ability to work independently and as part of a multidisciplinary team

This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.