Quality Validation SpecialistBelcan Corporation • Indianapolis, IN, US
No longer accepting applications
Quality Validation Specialist
Belcan Corporation • Indianapolis, IN, US
3 days ago
Job descriptionAssists in the development of cGMP operating procedures that relate to process, computer systems, and equipment validation. Assures compliance with SOPs upon implementation. Investigates and proposes additional corrective actions as required. Communicates with Field Quality / Operations and other Operational and Quality Assurance personnel where necessary on Donor Center compliance and cGMP issues. Assists in ensuring validation approaches are current to regulatory expectations and standards within the industry : Write test cases to validate critical control points, user requirements, and functional designs. Execute test cases as needed. Interacts with Donor Center and Field Quality / Operations personnel to facilitate validation testing to ensure timely and documented approval prior to implementation for routine use. Assists in analyzing validation data to ensure acceptance criteria are met. Assists in writing validation summaries. Ensure milestones and timelines are met on assigned projects. Prepares validation reports for distribution. Evaluates adequacy of corrective actions. Participates in the evaluation of processes, systems, and individual center equipment needs and final approval process : Prepares validation equipment for use at the Donor Center and for evaluation upon return. Assists in identifying and determining actions to add, remove, and / or revalidate processes, systems, and equipment, including evaluation of new / updated methodologies / applications / equipment and resolution of issues or problems with performance, transfer, or service. Tracks and monitors process / system failures / events. Provides feedback to Donor Center management regarding requirements, results from data collected, and validation processes. Tracks and monitors equipment calibration due dates and calibration failures / events. Provides feedback to Donor Center management regarding equipment calibration due dates, requirements, results from data collected, and validation processes. Monitors and trends customer complaints and nonconformance related to equipment failures. Bachelor's degree Strong knowledge of current Good Manufacturing Practices (cGMPs) operating procedures and standard operating procedures. Excellent quantitative and analytical skills. Excellent oral and written communication skills. Strong critical thinking and problem solving skills. Ability to identify errors and provide corrective action. Ability to work with others in a team environment. Knowledge of Microsoft Office applications and computer applications used in the Donor Centers. Beneficios m e9dicos / de salud con m faltiples opciones de planes, Cuentas de Gastos Flexibles, Seguro Dental y de la Vista Plan 401k Capacitaci f3n en el trabajo / capacitaci f3n cruzada Seguro de vida, seguro por discapacidad Seguro de vida voluntario para familiares disponible. Seguro de accidentes y enfermedades graves opcional. Evaluaciones de desempe f1o programadas Programa de referencias Colabora en el desarrollo de procedimientos operativos de buenas pr e1cticas de fabricaci f3n actuales (cGMP) relacionados con la validaci f3n de procesos, sistemas inform e1ticos y equipos. Garantiza el cumplimiento de los procedimientos operativos est e1ndar (POE) tras su implementaci f3n. Investiga y propone mediciones correctivas adicionales seg fan sea necesario. Se comunica con el personal de Calidad / Operaciones de Campo y con otro personal de Operaciones y Control de Calidad, cuando sea necesario, sobre el cumplimiento de las cGMP del Centro de Donaci f3n. Colabora en garantizar que los enfoques de validaci f3n cumplan con las expectativas y est e1ndares regulatorios del sector : Redacta casos de prueba para validar puntos cr edticos de control, requisitos de usuario y disenos funcionales. Ejecuta casos de prueba seg fan sea necesario. Interact a1a con el personal del Centro de Donaci f3n y del personal de Calidad / Operaciones de Campo para facilitar las pruebas de validaci f3n y garantizar la aprobaci f3n oportuna y documentada antes de la implementaci f3n para uso rutinario. Colabora en el an e1lisis de los datos de validaci f3n para garantizar el cumplimiento de los criterios de aceptaci f3n. Colabora en la redacci f3n de res famenes de validaci f3n. Garantizar el cumplimiento de los hitos y plazos en los proyectos asignados. Preparar informes de validaci f3n para su distribuci f3n. Eval far la idoneidad de las acciones correctivas. Participar en la evaluaci f3n de procesos, sistemas y necesidades de equipos de cada centro, as ed como en el proceso de aprobaci f3n final : Preparar los equipos de validaci f3n para su uso en el Centro de Donaci f3n y para su evaluaci f3n a su regreso. Ayudar a identificar y determinar las acciones para a f1adir, eliminar o revalidar procesos, sistemas y equipos, incluyendo la evaluaci f3n de metodolog edas, aplicaciones y equipos nuevos o actualizados, y la resoluci f3n de problemas de rendimiento, transferencia o servicio. Realizar el seguimiento y la supervisi f3n de fallos y eventos de procesos y sistemas. Proporcionar retroalimentaci f3n a la direcci f3n del Centro de Donaci f3n sobre los requisitos, los resultados de los datos recopilados y los procesos de validaci f3n. Realizar el seguimiento y la supervisi f3n de las fechas de vencimiento de la calibraci f3n de los equipos y de los fallos y eventos de calibraci f3n. Proporcionar retroalimentaci f3n a la direcci f3n del Centro de Donaci f3n sobre las fechas de vencimiento de la calibraci f3n de los equipos, los requisitos, los resultados de los datos recopilados y los procesos de validaci f3n. Monitorea y analiza las quejas de los clientes y las no conformidades relacionadas con fallas de los equipos.
Job Description
Job Title : Quality Validation Specialist
Pay Rate : $33.37 / hr
Location : Indianapolis, IN
Area Code : 317, 463
ZIP Code : 46227
Start Date : Right Away
Shift : 1st shift
Keywords : #QualityValidationSpecialist #QualityValidationJobs
Benefits
- Medical / Health Benefits with multiple plan options, Flexible Spending Accounts, Dental and Vision
- 401k
- On the job training / cross-training
- Life Insurance, disability insurance
- Voluntary life insurance for family members available.
- Accident and critical illness insurance optional.
- Scheduled performance reviews
- Referral program
Job Description
The Quality Validation Specialist ensures current Good Manufacturing Practices (cGMP) and FDA / Quality Systems are adhered to throughout the evaluation, review and approval of validation and quality assurance / control documentation.
Responsibilities
Education and Experience
Skills and Knowledge
Descripci f3n en Espal
Puesto : Especialista en Validaci f3n de Calidad
Salario : $33.37 / hora
Ubicaci f3n : Indian f3polis, IN
C f3digo de erea : 317, 463
C f3digo postal : 46227
Fecha de inicio : Inmediata
Turno : 1.er turno
Beneficios (Espal)
Descripci f3n del puesto (Espal)
El Especialista en Validaci f3n de Calidad garantiza el cumplimiento de las Buenas Pr e1cticas de Manufactura (cGMP) y los Sistemas de Calidad de la FDA durante la evaluaci f3n, revisi f3n y aprobaci f3n de la documentaci f3n de validaci f3n y control de calidad.
Responsabilidades (Espal)
Si est e1 interesado en este puesto, presente su solicitud a trav e9s del enlace Aplicar ahora proporcionado. Nuestro objetivo primordial es brindar soluciones de dotaci f3n de personal de calidad que ayuden a las personas, organizaciones y comunidades a tener e9xito. Belcan es un proveedor l 00edder de personal calificado para muchas de las empresas m e1s respetadas del mundo. Ofrecemos excelentes oportunidades para asignaciones por contrato, temporales, de contrataci f3n temporal y directas. Somos el empleador elegido por miles en todo el mundo. Para obtener m e1s informaci f3n, visite nuestro sitio web en Belcan.com
Belcan ofrece igualdad de oportunidades. Su solicitud y candidatura no se considerar e1n por motivos de raza, color, sexo, religions, credo, orientaci f3n sexual, identidad de g e9nero, origen nacional, discapacidad, informaci f3n gen e9tica, embarazo, condici f3n de veterano ni ninguna otra caracter edstica protegida por las leyes federales, estatales o locales.
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Quality Specialist • Indianapolis, IN, US
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