QA Specialist / Deviation Investigator
Jornada completa
QRC Group, LLC
QA Specialist / Deviation Investigator to lead investigations of deviations, non conformances, and quality events within a regulated manufacturing environment.
Key Responsibilities:
- Lead end‑to‑end investigations for deviations and quality events.
- Collect and analyze data, conduct interviews, and review technical documentation.
- Apply structured Root Cause Analysis tools (5 Whys, Fishbone, Fault Tree, etc.).
- Develop and manage effective CAPAs addressing true root causes.
- Prepare clear, compliant investigation reports aligned with GMP/GDP requirements.
- Collaborate with Operations, QA, Engineering, and other cross‑functional teams.
- Facilitate and lead problem‑solving and investigation meetings.
Requirements
- Minimum 3–5 years of experience in deviation investigations , QA operations, or quality systems in regulated environments.
- Experience with GMP/GDP environments and documentation.
- Proficiency with CAPA methodologies and root‑cause‑analysis tools.
Vacante publicada el 22 días atrás
Empleos similares que podrían interesarleBasado en la vacante QA Specialist / Deviation Investigator en Carolina
- ...Log on now to our website qrcgroup.com / to learn more about our services and solutions! Job Description QA Specialist / Deviation Investigator to lead investigations of deviations, non conformances, and quality events within a regulated manufacturing...SugeridoContrato
- ...experiences one sofa at a time. And as the Upholstery Sourcing Specialist, you'll serve as the strategic bridge between our internal... ...please do not engage. Forward the message to ****** so we can investigate. Equal Opportunity Statement: At Article, we value and...SugeridoPrácticaContratoPatrocinio de visaInicio inmediatoTrabajo por turnos
- ...sample collections in accordance with the applicable sampling plan or protocol and in compliance with procedural requirements. Support QA oversight of Site Utilities Systems and Environmental Monitoring results. Coordinate with impacted areas including the laboratory,...SugeridoTiempo completoCAS
- ...difference through our Corporate Social Responsibility activities Job Description Fairmont El San Juan Hotel Housekeeping Specialist is responsible of the administrative and clerical tasks of the housekeeping department. Works a liaison between the housekeeping...SugeridoTiempo completoEmpleo permanenteTrabajar en la oficina
- ...Sr. Validation Specialist to support manufacturing processes and equipment upgrades, replacements, and modifications in a manufacturing environment. Experience in: Manufacturing Process Methasys Validation Life Cycle Validation IQ, OQ, PQ Process and...SugeridoContrato
- ...scope, assumptions, and trade‑offs impacting cost, schedule, and system performance. • Review and approve technical submittals, deviations, and change requests with risk‑based decision making. • Hold vendors accountable for documentation, training, spares, and...Tiempo completoCAS
- ...Jr Validation Specialist with experience in regulated industries to c ollaborate with cross-functional teams to draft project schedules and plans. Knowledge of Validation Life Cycle, Regulations and Project Management Good technical writing skills Requirements...Contrato
- ...Specialist QA with experience in regulated industry and knowledge in: Environmental Monitoring, Microbial Identification (Micro ID... ...GMP areas. Provides assessments to change control records, deviations, audit processes that need support from the Environmental...ContratoTrabajar en la oficina
- ...GMP areas. ~ Provides assessments to change control records, deviations, audit processes that need support form the Environmental Control... ...Microbiology, Biology or Life Sciences ~4+ years of directly related QA experience in a regulated manufacturing environment ~...ContratoTrabajo por turnos
- Inteldot has over 15 years in the life sciences industry, with operations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico. Administrative Shift Job Description: Under minimal ...Tiempo completoTrabajar en la oficinaTrabajo por turnos
- ...Participate in resolution of technical issues, including those related to control strategy and manufacturing. Authoring of deviations and change controls. Build, manage, and maintain internal and external relationships, site management, development and central...Contrato
- ...Practices (cGLP), and other applicable regulations. • Ensure that deviations from established procedures are identified, reported, and... ...knowledge of manufacturing and distribution processes, including QA, QC, and Process Development operations. • Validated experience...Contrato
- ...Monitor / document effectively routinely operational parameters to ensure optimum control and regulatory compliance. Report any deviation. Provide maintenance to critical measurement equipment and tools, reporting failures and repair if necessary. Analyze fuel...Tiempo completoCASInicio inmediatoTurno de nocheTrabajo por turnos
- ...required. # If in charge of multiple buildings, may be accountable of additional Facilities Coordinators. # Support to any related Investigation and CAPA. Including Quality Calendar, Quality Plans, EHS Plan, Self-Inspections actions, BMP, C-Seguro actions. Perform Root...ContratistaTiempo completoContratoCASTrabajar en la oficinaInicio inmediatoTrabajo por turnos
- ...for manufacturing process changes • Support major/trend deviation investigations throughout the whole lifecycle including Root Cause... ...BOM's (Bill of Materials) • Serves as a peer-recognized specialist in at least one area, with overall responsibility for determining...Contrato
$55 por año
...our team as we help shape a brighter way forward. Quality Specialist We are seeking a Quality Specialist to join our pharmaceutical... ...(Word, Excel, PowerPoint, Outlook) Demonstrated ability to investigate issues, recognize trends, and diagnose patterns in quality...Pago diarioContratistaContratoTrabajar en la oficinaTrabajo por turnos- ...Company: Popular Workplace Type: Hybrid ISO Security Specialist General Description Provide technical support on Cyber... ...Duties and Responsibilities * Ability to manage security investigations through the entire incident lifecycle based on our Incident Response...PrácticaPatrocinio de visaInicio inmediatoTrabajo híbridoTrabajo por turnos
$45 000 - $61 000 por año
...employees on compliance matters. ~ Collaborate with internal stakeholders to develop and implement compliance strategies. ~ Investigate and address compliance-related incidents, violations, and complaints. ~ Stay updated with changes in laws and regulations...Tiempo completoTrabajar en la oficina- ...For QA Services in the Downstream a rea. WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree with five (5)... ...Approve planned incidents. Represent QA on NPI team. Lead investigations. Lead site audits. Own site quality program procedures. Designee...ContratoTrabajo por turnos
- ...functional teams to obtain project deliverables. ~ Experience in health, safety and compliance standards. ~ Experience with systems investigation and root cause analysis tools ~ Experience with a CMMS or asset preventive maintenance program. ~ Knowledge on Project...ContratistaTiempo completoContratoCAS
- ...manufacturing equipment, automated systems, utilities, and process deviations to ensure uninterrupted operations. Lead and execute the... ...systems, and facility infrastructure. Participate in investigations, CAPA development , and root cause analysis for process, equipment...Contrato
- ...for manufacturing process changes Support major/trend deviation investigations throughout the whole lifecycle including Root Cause Analysis... ...BOM's (Bill of Materials) Serves as a peer-recognized specialist in at least one area, with overall responsibility for determining...ContratoTrabajo por turnos
- ...Experience in handling deviations/non-conformances investigations. Skills for technical writ ing and development of reports. Knowledge and experience with root cause analysis tools (e.g. causal factors analysis, 5 Why’s). Project management skills on identifying...Contrato
- ...Spanish). Project Management skills. Shift: Administrative and according to business needs. Experience in: Deviations/non-conformances investigations. Technical writing and development of reports. Root cause analysis tools (e.g. causal factors analysis, 5...ContratoTrabajo por turnos
- ...our team as we help shape a brighter way forward. Document Specialist We are seeking a detail-oriented Document Specialist to... ...needs. * Provide administrative support for pest control investigations and incident reporting * Assist with training material preparation...Pago diarioTrabajar en la oficinaTrabajo por turnosLunes a viernes
- ...consultants to ensure timely delivery. Manage change controls and deviations related to plants and equipment. Support maintenance and... .... Provide expertise in troubleshooting and root cause investigations. Facilitate the transfer of technical knowledge across...Tiempo completoTrabajar en la oficina
- ...búsqueda de un/a profesional en el campo de la salud para estudios clínicos en jóvenes adultos puertorriqueños. Estos estudios de investigación se llevan a cabo en el área metropolitana extendida de Puerto Rico. Se contratará al candidato que posea las habilidades y...Por horaTiempo completoCon coche propioTurno de mañanaHorario flexibleTrabajo por turnosFin de semana
- ...brighter way forward. Job Purpose The Engineering Operations Specialist - Continuous Improvement is responsible for identifying,... .... Work Order & Operational Excellence Drive Good Saves investigations and ensure timely closures. Complete work order revision...Pago diario
- ...soon as factual information is available, and summarize closed investigations into the database accurately. Ensure complaint-related... ...depending on the nature and complexity of the complaint, the specialist may be responsible for conducting and documenting the investigation...ContratoTrabajar en la oficinaTrabajo por turnos
- ...) Enforce EHS policies, regulations, and programs (OSHA, EPA, and ISO standards). Conduct risk assessments, lead incident investigations, and drive the closure of corrective/preventive actions (CAPA) via the Enablon system. Lead training and orientation for new...ContratistaContratoTrabajo por turnos
¿Desea recibir más vacantes?
Suscríbase y reciba vacantes similares a QA Specialist / Deviation Investigator. ¡Sea el primero en aplicar!
