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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 QA is responsible for providing on-the-floor Quality Assurance (QA) oversight to ensure compliance with current Good Manufacturing Practices (cGMP), internal procedures, regulatory requirements, and quality standards. The role supports manufacturing operations through quality review and approval of records, investigations, validations, quality systems, and continuous improvement initiatives while serving as a key partner across multiple functional areas.
Key Responsibilities
Position Summary
The Specialist QA is responsible for providing on-the-floor Quality Assurance (QA) oversight to ensure compliance with current Good Manufacturing Practices (cGMP), internal procedures, regulatory requirements, and quality standards. The role supports manufacturing operations through quality review and approval of records, investigations, validations, quality systems, and continuous improvement initiatives while serving as a key partner across multiple functional areas.
Key Responsibilities
- Perform On-the-floor Plant Quality Assurance (PQA) review, approval, and tracking of cGMP processes, procedures, testing methods in manufacturing, documents and records, batch record review, MES, EBR, SAP, EDMQ, DQMS, Trackwise; including but not limited to deviations, CAPAs, and validations.
- Actively engage in continuous improvement initiatives, programs, and projects.
- Vigilantly ensure that changes potentially impacting product quality are assessed according to procedures.
- Certify that deviations from established procedures are investigated and documented per procedures and ensure on-the-floor triage is completed, documented, and current procedural controls are achieved, including ensuring the initiation of deviation records.
- Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
- Require strong collaboration and cross-functional partnership to ensure the Quality Management System, Manufacturing, Process Development, Validation, Quality Control, Warehouse, Engineering, Contractors, Environmental, Facilities, and other processes are executed according to established procedures.
- Serve as a strategic advisor to senior management regarding quality, compliance, supply, and safety risks.
- Support internal/external audits and inspections as part of the audit/inspection management team, including acting as Quality unit representative as needed.
- Accountable adherence to assigned training, permitting execution of required tasks.
- Champion continuous improvement initiatives and projects.
- Provide support and oversight into New Product Introduction (NPI).
- Demonstrate validated expertise in Quality Systems such as deviations, CAPA, and change control.
- Exhibit experience in computer systems validation or computer systems quality assurance, particularly with medical devices and/or consulting background technical proficiency.
- Possess robust knowledge and experience with processes involved in manufacturing and distribution, QA, QAL, and Process Development.
- Experience with validation of GxP applications, including development of Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) protocols, test scripts, and completion/summary report approvals per compliance requirements.
- Validated experience serving as Quality Contact for complex projects involving new products.
- Validated experience in commissioning and qualification.
- Strong organizational skills, including the ability to follow assignments through to completion.
- Enhanced skills in leading, influencing, and negotiating.
- Demonstrate the ability to interact effectively with regulatory agencies.
- Solid word processing, presentation, database, and spreadsheet application skills.
- Strong communication skills in English and Spanish (both written and oral), facilitation, and presentation skills.
- Proven skill in working independently and effectively interacting with all levels throughout the organization.
- Advanced data trending and evaluation abilities.
- Ability to evaluate compliance issues.
- Bachelor's Degree in Science, Engineering, Biotechnology, Chemistry, Biology, Pharmacy, or a related technical field.
- Minimum of 4 years of directly related experience in Quality Assurance within a regulated pharmaceutical, biotechnology, medical device, or related GxP environment.
- Strong knowledge of Quality Systems including: Deviations, CAPAs, Change Control, Investigations, Validation Programs.
- Experience with electronic quality and manufacturing systems such as MES, EBR, SAP, TrackWise, EDMQ, or equivalent platforms.
- Bilingual proficiency in English and Spanish (written and verbal).