AbbVie

Global biopharmaceutical company developing medicines

Quality Control Technician 1

Inspection & TestPosted on Nov 11

Full-timeHeredia Province, Heredia, Costa RicaNo salary listedIn-person

About the Job

Requirements

A high school education qualification (Bachiller en Educación Media) is required.
At least one year of experience in the medical industry or at least one year in a position within a Quality department is required.
Normal 20/20 vision, with corrective lenses if necessary, is required.
Good documentation practices are required.
Good manufacturing practices (GMPs) are required.
Basic proficiency with Microsoft Word and Excel is required.
Attention to detail is required.

Responsibilities

Perform daily quality assurance reviews of the manufacturing process to ensure subassemblies and in-process products are manufactured according to procedures and specifications.
Perform visual inspections and functional tests on in-process products and subassemblies to ensure they meet established procedural specifications.
Review device history records (DHR) before product or subassembly release to ensure documentation meets applicable specifications.
Perform daily tests to verify that primary packaging meets specifications required to maintain the products’ sterile barrier.
Quarantine nonconforming products by correctly identifying retained material, submitting the corresponding report, and blocking or unblocking the material in SAP.
Review temperature records, graphs, and indicators to ensure product sterility.
Keep work areas organized according to 5S practices and meet the applicable Quality objectives for each period.
Complete tasks assigned by the supervisor.
Report any failure to comply with established procedures and regulations for the area.
Comply with corporate and legal EHS requirements by following internal policies and procedures, and support compliance through appropriate strategies, internal controls, communication, and training.
Continuously support EHS results through leadership, commitment, and active participation in EHS initiatives.

Desired Qualifications

A QA technician qualification or at least 25% progress toward a STEM degree is desirable.

Job Description

Ejecutar actividades específicas de control y aseguramiento de calidad con el objetivo de asegurar
que los componentes y productos se manufacturen de acuerdo con los procedimientos y cumplan
con las especificaciones correspondientes.

Realizar auditorías (QA Reviews) diarias al proceso de manufactura con el fin de
asegurar que los subensambles y productos en proceso se manufacturen de
acuerdo con los procedimientos y especificaciones correspondientes.
Realizar inspecciones visuales y pruebas funcionales al producto y
subensambles en proceso que aseguren el cumplimiento de las especificaciones
establecidas en nuestros procedimientos.
Revisar los registros históricos del dispositivo (DHR) antes de la liberación del
producto o subensamble, para asegurar que la documentación en el mismo
cumpla con las especificaciones correspondientes.
Realizar pruebas diarias que aseguren que los empaques primarios cumplen con
las especificaciones correspondientes que aseguran la barrera estéril de
nuestros productos.
Realizar la retención (puesta en cuarentena) de productos no-conformes:
Identificación correcta del material retenido, reporte respectivo, bloqueo y/o
desbloqueo en SAP.
Revisar registros, gráficas e indicadores de temperatura para asegurar la
esterilidad del producto
Mantener las áreas ordenadas (5’s), cumplir los GO’s de Calidad de cada
periodo correspondiente.
Hacer las tareas asignadas por su supervisor.
Reportar cualquier incumplimiento de los procedimientos y regulaciones
establecidas para el área.
Atender el cumplimiento de los requerimientos corporativos y legales de
EHS, mediante el acatamiento de la política y los procedimientos internos. Así
mismo, garantizar el cumplimiento mediante la adopción de estrategias,
controles internos comunicación y entrenamientos necesarios.
Mantener continuamente los resultados de EHS a través del liderazgo, el
compromiso y la participación activa en todas las iniciativas relacionadas con
EHS

Qualifications

Educación y Experiencia

Bachiller en Educación Media.
Al menos un año de experiencia en industria médica, o experiencia de al menos un año en posiciones dentro de un departamento de Calidad (aunque no sea en industria médica).
Deseable técnico de QA, o un 25% de avance en carrera STEM

Requerimientos físicos del ambiente de trabajo

Agudeza Visual: Visión normal 20/20 (de ser necesario con lentes) es requerido para la posición.

Otras habilidades profesionales:

Buenas prácticas de documentación
Buenas prácticas de manufactura (GMPs)
Office (Word y Excel) basico.
Enfocado al detalle.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

About the Company

AbbVie

Global biopharmaceutical company developing medicines

AbbVie is a global biopharmaceutical company that develops and sells medicines to treat serious health conditions. Its portfolio spans immunology, oncology, virology, neuroscience, and aesthetics, with products designed to modulate the immune system, target disease pathways, or support medical aesthetics. AbbVie compounds its products through a heavy emphasis on research and development, investing billions to build a steady pipeline of new therapies. Its medicines are brought to market by selling to healthcare providers, hospitals, and clinics, and in some cases directly to patients via prescriptions. The company differentiates itself through a wide, globally distributed product line, substantial R&D investment, and a commitment to sustainability and patient care, including science-based targets. AbbVie’s goal is to improve patient outcomes by delivering effective treatments for unmet medical needs while pursuing long-term, responsible growth across healthcare markets.

Company size: 10,001+
Company stage: IPO
Headquarters: North Chicago, IL
Founded: 1888

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