Specialist Quality Control - 35983

Mirus Consulting Group; Juncos (PR); Presencial; USD 85.000 - 110.000; Jornada completa

Descripción de la vacante

mîrus Consulting Group in Humacao, Puerto Rico, specializes in QC and IT validation for pharmaceutical clients. The Specialist Quality Control role focuses on deviation management, lab investigations, and maintaining regulatory compliance within a cGMP environment.

You will collaborate with cross-functional teams to resolve quality events, support CAPA and Change Controls, and apply microbiology and analytical testing expertise to drive continuous improvement across the site.

Formación

• Doctorate or Master’s degree with 2+ years of related experience OR Bachelor’s degree with 4+ years of related experience.

Responsabilidades

• Lead and manage Quality Control deviations.
• Represent QC deviation processes and ensure timely closure and compliance with site procedures.
• Evaluate issues related to Microbiology testing, HPLC analyses, and analytical methods.
• Review laboratory data and analytical results to identify trends and opportunities for improvement.
• Collaborate with QA, Manufacturing, Validation and other teams to resolve quality events and implement corrective actions.
• Support Change Controls, Risk Assessments, and CAPA activities in QC operations.
• Ensure compliance with cGMP, data integrity, site procedures, and global quality standards.
• Support internal audits, regulatory inspections, and responses to quality-related observations.
• Provide technical guidance regarding microbiological and analytical testing investigations.

Conocimientos

Quality Control Deviations

Microbiology

HPLC troubleshooting

Analytical methods

OOS/OOT

CAPA

Change Control

Risk Assessment

Root Cause Analysis

Technical Writing

Educación

Doctorate degree

Master’s degree

Bachelor’s degree

Descripción del empleo

mîrus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States. Its services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the project management involved.

Position Summary

The Specialist Quality Control is responsible for supporting Quality Control operations with a strong focus on deviation management, laboratory investigations, and compliance within a regulated manufacturing environment. This role will collaborate with cross-functional teams to ensure timely resolution of quality events, maintain compliance with applicable procedures and regulatory requirements, and support continuous improvement initiatives. Experience in microbiology, analytical testing, and laboratory systems is highly desirable.

Key Responsibilities

• Lead and manage Quality Control deviations.
• Serve as the primary Quality Control representative for deviation processes, ensuring timely closure and compliance with site procedures and regulatory expectations.
• Utilize scientific and technical knowledge to evaluate issues related to Microbiology testing, HPLC analyses, and analytical laboratory methods.
• Review laboratory data and analytical results to identify trends, potential risks, and opportunities for continuous improvement.
• Collaborate with Quality Assurance, Manufacturing, Validation, and other cross-functional teams to resolve quality events and implement effective corrective actions.
• Support Change Controls, Risk Assessments, and CAPA activities associated with Quality Control operations.
• Ensure compliance with cGMP regulations, data integrity requirements, site procedures, and global quality standards.
• Support internal audits, regulatory inspections, and responses to quality-related observations.
• Provide technical support and guidance regarding microbiological and analytical testing investigations.

Basic Qualifications

• Doctorate degree OR

• Master’s degree and 2 years of directly related experience OR
• Bachelor’s degree and 4 years of directly related experience

Preferred Qualifications

• Hands-on experience managing Quality Control deviations in a pharmaceutical, biotechnology, or medical device environment.
• Strong background in Microbiology laboratory testing and investigation activities.
• Experience operating and troubleshooting HPLC systems.
• Knowledge of analytical laboratory methods, method troubleshooting, and data interpretation.
• Experience with OOS, OOT, CAPA, Change Control, and Risk Assessment processes.
• Strong investigation, technical writing, and root cause analysis skills.

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.