- Mentor Technical Group (Juncos, PR)
- …* Laboratory experience in a GMP environment within the Pharmaceutical and/or Biotech industry * Fully bilingual communications skills (English and Spanish) * Good ... communications and presentation skills in English and Spanish * Project management skills * Strong organizational skills, including ability to follow assignments through to completion * Enhanced skills in leading, influencing and negotiating * Knowledge of and… more
- Mentor Technical Group (Juncos, PR)
- …Scientific Background (Science or Engineering) with experience in Pharmaceutical Industry, Quality Control , Laboratory Testing, Project Management and Quality ... Method Validation (Experience preferable) + Strong knowledge and experience with quality process management + Basic Knowledge on equipment preventive maintenance and… more
- CSL Plasma (Loiza, PR)
- …Opportunity** This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with ... are adhered in order to support the operations and quality requirements for business operations. + Reporting compliance status...1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act.… more
- Mentor Technical Group (Juncos, PR)
- …Mexico, Germany, Canada, and South America. Responsibilities: + Expertise in Quality Systems such as Deviations (Non-conformities, CAPA, and Change Control ... approvals as per the compliance requirements. + Validated experience as Quality Contact for sophisticated projects involving new drug substance/products with… more
- Quality Consulting Group (Juncos, PR)
- …field corrective actions, CAPA, or product quality management. + Experience on Quality Systems & CAPA, Change Control and Validations. + Solid understanding ... QUALITY CONSULTING GROUP, a leader in the pharmaceutical,...external stakeholders. + Proficiency in Microsoft Office Suite and quality management systems (QMS). + Strong technical writing. +… more
- Mentor Technical Group (Juncos, PR)
- …and installation phases. + Perform risk assessments and identify critical quality attributes (CQAs) and critical process parameters (CPPs). + Document and ... and regulatory standards. + Collaborate with engineering, manufacturing, and quality teams to ensure seamless equipment qualification and process transfer.… more
- Mentor Technical Group (Juncos, PR)
- …document lifecycle using electronic document management systems (EDMS), including version control , approvals, and archival. + Support internal and external audits by ... industry (pharma, biotech, medical devices) with direct experience in SOP writing or quality documentation. + Knowledge of regulations such as FDA 21 CFR Part 11,… more