mîrus Consulting Group is a Puerto Rico based technical services firm headquartered in Humacao. The company specializes in Computer System Validation (CSV) and Information Technology consulting for the pharmaceutical and life sciences industries across Puerto Rico and parts of the United States. Its services include the assessment and validation of automation systems, network infrastructures, and business processes, as well as comprehensive project management support to ensure compliance, efficiency, and operational excellence.
Position Summary The SpecialistQuality Assurance provides quality oversight and compliance support for pharmaceutical Drug Substance (API) manufacturing operations within a GMP-regulated environment. This role plays a critical part in ensuring that manufacturing, testing, storage, and distribution activities comply with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (cGLP), and applicable regulatory requirements. The Specialist QA partners cross-functionally to support quality systems execution, batch disposition, deviation management, change control, audits, and New Product Introduction (NPI) activities, while actively promoting continuous improvement and compliance excellence.
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).
Qualifications Doctorate degreeor
Master’s degree and 2 years of Quality or Manufacturing support experience in pharmaceutical, GMP regulated environment or
Bachelor’s degree and 4 years of Quality Manufacturing support experience in pharmaceutical, GMP regulated environment
Educational background in Life Sciences and/or Engineering. (preferred)
Night Shift: 5:00pm-5:30AM
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.
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.