GMP Documentation Specialist
Jornada completa
QRC Group
QRC Group is seeking a GMP Documentation Specialist to support the C&Q team on a laboratory renovation at a pharmaceutical manufacturing site. The role works directly with the Construction Manager and General Contractor so that GMP documentation is built correctly from the start of construction, preventing gaps at system turnover.
Responsibilities
- Guide the contractor on GMP documentation requirements throughout construction.
- Oversee test certifications, Mechanical Completion documentation and Turnover Package (TOP) content and readiness.
- Monitor documentation progress from early construction and close gaps before turnover.
- Create CMMS service requests for new equipment, instruments and assets, and develop or revise job plans.
- Request spare parts from contractors and track them until quotes are received and loaded in CMMS.
- Maintain documentation trackers and report status to the CQV Lead.
Requirements
- Associate’s or Bachelor’s degree in Engineering, Science or a related field.
- 3+ years in GMP documentation or document control on pharmaceutical capital projects.
- Experience with turnover packages, mechanical completion and contractor documentation.
- CMMS experience (Maximo preferred): asset setup, job plans and spare parts.
- Strong organization and follow-up skills; advanced Excel.
- Fully bilingual (English / Spanish).
Vacante publicada el 2 días atrás
Empleos similares que podrían interesarleBasado en la vacante GMP Documentation Specialist en Manatí
- ...Computer System Validation Specialist to support validation and qualification... ...implementation, testing, and documentation . Key Responsibilities... ...and execute test scripts and document test results, deviations, and... ...with applicable GxP, GMP, and data integrity requirements...SugeridoTiempo completoHorario flexibleTrabajo por turnos
- ...comprehensive assessment of the site's Quality Management System, GMP records, system interfaces, batch release processes, and end-to-... .... Evaluate GMP record management processes, including document generation, review, approval, retention, and archival. Assess...SugeridoContrato
- ...in accordance with project requirements, company procedures, GMP expectations , and applicable industry standards. The role... ...commissioning tests, qualification protocols, reports, and turnover documentation. Apply risk-based commissioning and qualification...SugeridoContratistaTiempo completoContrato
- ...complying with the EHS policies. Ensure that all documents are completed complying with the GMP’s practices when required. Provide cover for other... ...of generators and fire pumps data taking Monitor / document effectively routinely operational parameters to ensure...SugeridoTiempo completoInicio inmediatoTurno de nocheTrabajo por turnos
- ...America. Responsibilities: 1. Performs all functions listed below with direct supervision. 2. Perform activities related with Documentation according to project assignment, customers’ needs and requirements and in compliance with cGMP’s and Safety procedures 3....SugeridoTiempo completo
- ...management skills. Preferred Qualifications PMP Certification. Lean Six Sigma Certification. Experience working in active GMP manufacturing facilities. Experience with commissioning, qualification, and validation activities. Knowledge of capital project...ContratistaPrácticaContrato
- ...including MicroStation and AutoCAD (conversion between the two). Reading and interpreting blueprints, drawings, and as-built documents. Document/version control systems (e.g., IDEA) for engineering drawing management. Field verification and red-line/as-built...ContratoTrabajo por turnos
- ...needs. Experience in: Project Schedule & Budgeting Project Coordination Process Optimization Technical Writing and Documentation The Personality Part: ~ Our Next Piece is someone who treats everyone they meet like family, especially our resources,...Trabajo por turnos
- ...preventive maintenance forms. Development and approval of GxP and automation impact assessments. Provide alternatives to resolve documentation situations. Establish project communication and documentation controls. Assure consistent quality of activities that meets...ContratoTrabajar en la oficina
- ...speech and language rehabilitation needs. Identifying issues and modifying speech therapy treatment if necessary. Tracking and documenting patient performance, progress, and response to treatment. Celebrating patient victories along the way. Qualifications...Tiempo completoRemoto
- ..., quality, and compliance. Provide status updates and reporting to stakeholders and leadership. Support project closeout, documentation, and systems handover BEING A FITS PIECE COMES WITH PERKS: ~ One of these is the excellent, unmatched, never-before-seen customer...Contrato
- ...QualityReviews (PQR), Drug Master Files (DMF) or any other regulatory document to assure compliance and proper documentation according to... ...Industry with at least 2 years as Regulatory / Compliance Specialist ~ Willing to work irregular and/or extended shifts if needed...ContratoTrabajar en la oficinaTrabajo por turnos
- ...incidents, near misses and property damage incidents. ~ Ensure follow-up is done to minimize future exposure and proper records/documents are maintained. ~ Conduct, coordinate and track various training to support company programs. ~ Conduct routine safety observations...Tiempo completoCAS
- ...placement and retention. Conduct weekly training workshops on career preparation topics and instruct Career Prep students. Document all placement services provided to graduates in case notes and verify placements with employers. Establish relationships with community...Tiempo parcial
$12 - $13 por hora
...ACTIVIDADES: • Interpretar, rotular y despachar recetas médicas conforme a las regulaciones federales y estatales. • Procesar y documentar recetas en RX30 garantizando precisión y cumplimiento regulatorio. • Gestionar recetas de medicamentos controlados mediante los...Tiempo parcialPrácticaFin de semanaAppleOne
ManatíHace un mes- ...laboratory systems. developing, reviewing, and executing C&Q documentation and protocols. supporting deviations, change controls, non-... ...accordance with applicable health, safety, environmental, quality, and GMP requirements. WHO WE ARE: We are a Service Provider...ContratistaContrato
- ...ensuring timely daily distribution in accordance with departmental protocols Execute document copying and scanning procedures for Outreach and admission (OA) and Career Transition Specialist (CTS) file systems with meticulous accuracy Generate comprehensive reports...Tiempo completoTrabajar en la oficina
- ...for manufacturing equipment. Qualification, validation, and lifecycle management of manufacturing systems and equipment. GMP documentation development, including protocols, reports, risk assessments, deviations, and CAPAs. Manufacturing process support,...ContratoTurno de tardeTrabajo por turnos
- ...engineering needs. Developing, reviewing, and maintaining technical documentation. Facility systems, equipment, utilities, and infrastructure.... ...and engineering activities are aligned with applicable GMP, safety, quality, and site requirements. Provide timely technical...ContratistaContratoInicio inmediatoTrabajo por turnos
- ...complying with the EHS policies. Ensure that all documents are completed complying with the GMP’s practices when required. Provide cover for other... ...generators and fire pumps data taking. Monitor / document effectively routinely operational parameters to ensure...Tiempo completoCASInicio inmediatoTurno de nocheTrabajo por turnos
- ...deliverables to project leadership Support change control and documentation within GxP environments Requirements Bachelor's... ...Solid understanding of GxP environments and regulatory frameworks (GMP / GAMP5) Experience coordinating with automation and...
- ...automation progress, risks, and deliverables Oversee change control, documentation, and data integrity within GxP environments Requirements... ...understanding of GxP environments and regulatory frameworks (GMP / GAMP5 / 21 CFR Part 11) Experience integrating automation...RemotoTrabajo híbrido
- ...Mechanical Engineering ~0-2 years of relevant experience in Quality Manufacturing or Supplier Quality Engineering, preferably in medical device industry. ~ Bilingual (Spanish/English) ~ Knowledge with equipment validation, documentation, and process implementation....Tiempo completo
- ...Maximo, MRO, Laboratory Supplies, Project Equipment), cells and final product. Communicate discrepancies related to materials and/or documents received. Archive documents of materials and merchandise received. Perform and assist in the coordination of the packaging...TemporalTiempo completoTrabajo por turnos
- ...Experience with brownfield/capacity-expansion projects preferred Solid understanding of GxP environments and regulatory frameworks (GMP / GAMP5) Experience managing cross-functional teams across Process, Automation, Engineering, and Quality Strong vendor and...Contratista
- ...safety regulations. Coordinate with clients, local agencies, and utility companies. Review and update project drawings and documentation. Build strong client relationships by providing exceptional customer service. Perform additional project-related duties as...SubcontratistaTiempo completo
- ...performing security investigations in an industrial manufacturing environment. This job requires ability to work with multiple documentation, including policies and procedures. Requires ability to analyze extensive written information. The incumbent needs to...TemporalTiempo completo
- ...Engineers that will supports the development, validation, and implementation of new manufacturing processes. The role involves documentation generation, process optimization, and cross-functional collaboration. Responsibilities : Perform process validation and equipment...ContratistaTiempo completo
- ...Interacts with clients and provides exceptional customer service that exceeds expectations. Experience working with submittal and RFI documents. Work with a smart, exciting group to help customers save money and go green! Additional duties required as needed....SubcontratistaTiempo completoTrabajar en la oficina
- ...Participate in Kaizen events, improvement workshops, Gemba walks, and structured problem-solving activities. Collect baseline data and document current conditions before implementing improvements. Measure results after implementation to confirm that project objectives...Tiempo completoTrabajar en la oficinaLunes a viernes
¿Desea recibir más vacantes?
Suscríbase y reciba vacantes similares a GMP Documentation Specialist. ¡Sea el primero en aplicar!
