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 Quality oversight and support to pharmaceutical manufacturing and testing operations to ensure compliance with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (cGLP), and applicable regulatory requirements. This role supports clinical and commercial Drug Substance (API) activities, ensures product quality, and contributes to continuous improvement and regulatory readiness.
Education and Experience Requirements Qualified candidates must meet one of the following education and experience combinations:
Doctorate degree OR
Master’s degree with 2 years of Quality or Manufacturing support experience in a pharmaceutical, GMP-regulated environment OR
Bachelor’s degree with 4 years of Quality or Manufacturing support experience in a pharmaceutical, GMP-regulated environment
Educational background in Life Sciences and/or Engineering is preferred.
Key Responsibilities
Execute Quality disposition (approval or rejection) of bulk drug substances.
Provide Quality oversight to ensure that operations for clinical and licensed pharmaceutical Drug Substance (API) are manufactured, tested, stored, and managed according to current Good Manufacturing Practices (cGMP), Good Laboratory Practices (cGLP), and other applicable regulations.
Ensure that deviations from established procedures are identified, reported, and documented per procedures.
Ensure that changes that could potentially impact drug substance quality are assessed according to procedures.
Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
Ensure that facilities, equipment, materials, organization, processes, and procedures align with cGMP practices and other applicable regulations.
Champion continuous improvement initiatives, programs, and projects, including developing efficiency projects and supervising progress.
Ensure completion of required training and maintain assigned training adherence to support successful task execution.
Collaborate and partner cross functionally to ensure the Quality Management System (QMS) processes are completed in accordance with established procedures.
Support internal and external audits and inspections as part of the audit/inspection management team, including acting as Quality Unit representative as needed.
Alert senior management of quality, compliance, supply, and safety risks.
Provide support and oversight for New Product Introduction (NPI).
Preferred Qualifications
Expertise in Quality Systems, including Deviations (Non conformities), CAPA, and Change Control.
Experience with key electronic systems, such as documentation platforms (e.g., CDOCS), Maximo, TrackWise, LIMS, MES/electronic batch record systems, and SAP.
Experience in computer systems validation (CSV) or computer systems quality assurance, including consulting level technical proficiency.
Experience with validation of GxP applications, including Validation Master Plans, GxP risk assessments, IQ/OQ/PQ protocols, test scripts, and summary/approval reports.
Robust knowledge of manufacturing and distribution processes, including QA, QC, and Process Development operations.
Validated experience serving as Quality Contact for complex projects involving packaging, inspection, commissioning, qualification, and new drug substances/products.
Strong organizational skills, with the ability to drive assignments through successful completion.
Demonstrated leadership, influencing, and negotiation skills, including interactions with regulatory agencies and evaluation of compliance issues.
Strong communication skills (written and oral), facilitation abilities, and full bilingual proficiency in English and Spanish, with the ability to work independently and effectively across all organizational levels.
Shift
Night shift: 5:00 pm – 5:30 am
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.