Specialist QA - 35845

Mirus Consulting Group; Juncos (PR); Presencial; USD 60 000 - 90 000; Tempo integral

Resumo da oferta

mîrus Consulting Group is seeking a Specialist QA to support quality assurance activities for manufacturing and new product implementation projects. The ideal candidate will have experience in New Product Introduction (NPI), Change Control, Factory Acceptance Testing (FAT), Validation, and Process Performance Qualification (PPQ) within a regulated environment.

The role involves collaborating with Manufacturing, Engineering, Validation, and Operations to ensure regulatory compliance and quality

Qualificações

• Experience with quality assurance activities in manufacturing and product introduction.
• Knowledge of regulatory requirements and GMP/quality standards.

Responsabilidades

• Support and oversee New Product Introduction (NPI) activities to ensure compliance with quality requirements.
• Manage and review Change Control processes and associated documentation.
• Participate in and support Factory Acceptance Tests (FATs) for new equipment and systems.
• Review, execute, and approve validation protocols and reports.
• Support Process Performance Qualifications (PPQs) and related quality activities.
• Ensure compliance with applicable regulatory requirements, quality standards, and company procedures.
• Collaborate with cross-functional teams including Manufacturing, Engineering, Validation, and Operations.

Conhecimentos

NPI

Change Control

FAT

Validation

PPQ

Formação académica

Doctorate Degree

Master's Degree with 2 years of experience

Bachelor's Degree with 4 years of experience

Descrição da oferta de emprego

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.

Job Summary

We are seeking a Specialist QA to support quality assurance activities for manufacturing and new product implementation projects. The ideal candidate will have experience in New Product Introduction (NPI), Change Control, Factory Acceptance Testing (FAT), Validation, and Process Performance Qualification (PPQ) within a regulated environment.

Key Responsibilities

• Support and oversee New Product Introduction (NPI) activities to ensure compliance with quality requirements.
• Manage and review Change Control processes and associated documentation.
• Participate in and support Factory Acceptance Tests (FATs) for new equipment and systems.
• Review, execute, and approve validation protocols and reports.
• Support Process Performance Qualifications (PPQs) and related quality activities.
• Ensure compliance with applicable regulatory requirements, quality standards, and company procedures.
• Collaborate with cross-functional teams including Manufacturing, Engineering, Validation, and Operations.

Minimum 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.

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.