- Mentor Technical Group (Juncos, PR)
- …Dominican Republic, Mexico, Germany, Canada, and South America. Responsibilities: + Quality Professional with Manufacturing Process Audit and Batch Record Review ... experience. + Available for non-standard shifts which include nights and weekends. + Basic knowledge of the process, PASx/MES application, MAXIMO, SAP, and LIMS. Education & Qualifications + Bachelor's degree and 5 years of directly related experience or… 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
- Mentor Technical Group (Juncos, PR)
- … QA on NPI team. + Lead investigations. + Lead site audits. + Own site quality program procedures. + Designee for QA manager on local CCRB. + Review Risk ... process validation protocols and reports for manufacturing processes. + Request Quality on incident triage team. + Approve Environmental Characterization reports. +… more
- CSL Plasma (Loiza, PR)
- …policies and processes at the center level. You will report to the Assistant Manager Quality **The Role** + Perform final QA review and release for all shipment ... Opportunity** This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with… more
- Quality Consulting Group (Juncos, PR)
- …requests in support of government investigations or litigations. + Ensures the quality assurance programs and policies are maintained and modified regularly. ... QUALITY CONSULTING GROUP, a leader in the pharmaceutical,...+ Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance… more
- Mentor Technical Group (Juncos, PR)
- …regulatory and company standards. + Collaborate with cross-functional teams (eg, QA , QC, Manufacturing, R&D, Regulatory) to gather process information and ensure ... 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
- Mentor Technical Group (Juncos, PR)
- …* Knowledge of and experience with processes involved in manufacturing and distribution, QA , QC, validation and process development * Basic Knowledge and skills of ... word processing, presentations, and spreadsheet applications Qualifications Requirements/Knowledge/Education/Skills: * Educational background in Chemistry, Microbiology, Biology or Life Sciences Mentor Technical Group es un empleador que ofrece igualdad de… more
- Mentor Technical Group (Juncos, PR)
- …reports. + Collaborate with cross-functional teams including Engineering, Operations, and QA /QC to ensure regulatory compliance. + Identify risks and opportunities ... for process and equipment improvement. + Provide support during internal and external audits related to CQV activities. + Maintain accurate and up-to-date CQV records and documentation in accordance with industry standards. Qualifications / Requirements: +… more