Specialist QA
mîrus Consulting Group View all jobs
- Juncos, PR
- Permanent
- Full-time
The Specialist QA is responsible for supporting and maintaining Quality Systems and Validation activities related to equipment, processes, and facilities within a regulated manufacturing environment. This role ensures compliance with internal procedures and applicable regulatory requirements while supporting continuous improvement, operational excellence, and audit readiness. The position requires strong technical expertise in Quality Systems, including Deviations, CAPAs, and Change Controls, as well as experience in validation lifecycle activities. The role works cross-functionally with Engineering, Operations, Quality, and Supply Chain teams to ensure validated states are maintained and quality standards are consistently met.Key Responsibilities
- Manage and support Quality Systems, including Deviation management, CAPA development, Change Control execution, and investigations.
- Lead and/or support validation activities for equipment, processes, and facilities, ensuring compliance throughout the validation lifecycle.
- Review, approve, and maintain validation documentation, protocols, reports, and supporting technical records.
- Ensure validation and quality activities comply with cGMPs, internal SOPs, and regulatory requirements.
- Support audit readiness activities and participate in internal, external, and regulatory audits as required.
- Collaborate with cross-functional teams to assess impact, mitigate risks, and implement effective quality solutions.
- Analyze trends, metrics, and quality data to identify opportunities for process improvement.
- Support implementation and maintenance of electronic systems used in Quality and Operations environments.
- Maintain accurate documentation and ensure timely completion of assigned quality and validation tasks.
- Available to support operations as needed, including weekends, holidays, and on-site presence.
One of the following education and experience combinations is required:
- Doctorate degree OR
- Master’s degree plus 2 years of experience in Quality Systems (Deviations, CAPAs, Change Controls) and Equipment, Process, and Facilities Validation OR
- Bachelor’s degree plus 4 years of experience in Quality Systems and Validation
- Proven experience as a Quality Professional within regulated manufacturing environments.
- Strong hands-on experience with Quality Systems and Validation programs.
- Familiarity with\or working knowledge of the following systems is highly desirable:
- PASx / MES
- MAXIMO
- SAP
- LIMS
- QMTS
- Veeva