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Specialist Quality Complaints - 35796
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
We are seeking a highly qualified Specialist Quality Complaints to support complaint management activities within a regulated pharmaceutical and biotechnology manufacturing environment. The successful candidate will be responsible for leading complaint investigations, performing root cause analyses, driving CAPA determinations, and ensuring compliance with applicable quality standards, procedures, and regulatory requirements.
This role requires strong analytical skills, project management experience, a quality-focused mindset, and the ability to effectively collaborate with cross-functional teams to ensure timely and compliant resolution of product quality complaints.
Key Responsibilities
Position Summary
We are seeking a highly qualified Specialist Quality Complaints to support complaint management activities within a regulated pharmaceutical and biotechnology manufacturing environment. The successful candidate will be responsible for leading complaint investigations, performing root cause analyses, driving CAPA determinations, and ensuring compliance with applicable quality standards, procedures, and regulatory requirements.
This role requires strong analytical skills, project management experience, a quality-focused mindset, and the ability to effectively collaborate with cross-functional teams to ensure timely and compliant resolution of product quality complaints.
Key Responsibilities
- Lead and coordinate product quality complaint investigations from initiation through closure.
- Perform comprehensive root cause analyses using structured problem-solving methodologies.
- Develop, assess, and support Corrective and Preventive Action (CAPA) plans to address identified issues and prevent recurrence.
- Ensure complaint records, investigations, and associated documentation comply with internal procedures and regulatory requirements.
- Collaborate with Manufacturing, Quality Assurance, Quality Control, Engineering, Regulatory Affairs, and other functional groups to support investigations and implement corrective actions.
- Track investigation milestones and drive timely execution of commitments through effective project management practices.
- Evaluate complaint trends and identify opportunities for continuous improvement.
- Support internal audits, inspections, and regulatory inquiries related to complaint handling processes.
- Present investigation findings and quality recommendations to management and cross-functional stakeholders.
- Maintain a strong focus on compliance, patient safety, and product quality.
- Candidates must meet one of the following requirements:
- Doctorate Degree OR
- Master's Degree and 2 years of directly related experience OR
- Bachelor's Degree and 4 years of directly related experience.
- Experience in complaint handling, quality investigations, or quality systems within the pharmaceutical, biotechnology, medical device, or regulated manufacturing industries.
- Strong project management experience with the ability to manage multiple investigations simultaneously.
- Demonstrated expertise in root cause analysis methodologies and CAPA determination.
- Deep understanding of quality systems, GxP regulations, and compliance requirements.
- Excellent problem-solving, analytical, and decision-making skills.
- Effective verbal and written communication skills.
- Strong interpersonal skills with the ability to work in cross-functional environments.
- Proficiency with Microsoft Office applications, including Excel and Outlook.
- Experience utilizing Microsoft Teams for collaboration and communication.