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.
Position Summary The Specialist Quality Control provides comprehensive quality control and laboratory support within a pharmaceutical manufacturing environment. This role is responsible for executing and supporting laboratory testing, data analysis, validation activities, quality processes, and project‑based initiatives, while ensuring compliance with cGMP, regulatory requirements, and internal quality systems. The Specialist QC applies scientific judgment, analytical skills, and strong technical documentation practices to support manufacturing, validation, and inspection readiness activities.
Key Responsibilities
Perform and support Quality Control laboratory activities, including execution, review, and interpretation of analytical and/or microbiological data.
Analyze scientific and laboratory data to support product quality, investigations, and decision‑making.
Prepare, review, and maintain technical documentation, protocols, reports, and quality records in compliance with cGMP requirements.
Provide support for quality processes, including deviations, CAPAs, change controls, investigations, and continuous improvement initiatives.
Support computer system validation (CSV) and analytical/method validation activities as applicable.
Support equipment qualification, validation, and troubleshooting activities, including review of qualification documentation.
Develop inspection, qualification, or validation protocols within aggressive timelines as required.
Effectively manage multiple priorities while maintaining focus on critical quality and compliance tasks.
Support project management activities, including coordination with cross‑functional teams (QC, QA, Manufacturing, Validation, Engineering).
Utilize laboratory and quality systems in compliance with data integrity principles.
Participate in internal and external audits, inspections, and regulatory interactions as needed.
Promote a strong culture of quality, compliance, and continuous improvement.
Requirements Candidates must meet one of the following minimum qualifications:
Doctorate degree, 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
Scientific or Engineering background with experience in the pharmaceutical industry, Quality Control, laboratory testing, project management, and/or quality processes.
Preferred Qualifications
Experience in disciplines such as Microbiology, Chemistry, Biochemistry, Molecular Sciences, or Chemical Engineering.
Strong experience in scientific data analysis.
Strong technical writing skills in English and Spanish, with emphasis on quality and regulatory documentation.
Advanced proficiency in Microsoft Excel for data analysis and trending.
Knowledge and experience in quality process management.
Experience or exposure to computer system validation (CSV) and method validation is preferred.
Experience supporting equipment validation and troubleshooting.
Ability to prioritize critical tasks in a fast‑paced environment.
Strong project management, communication, and negotiation skills.
Familiarity with KNEAT platform and Kaye Validator systems is preferred.
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.