Analyst, Quality at Baxter International

Cali, Valle del Cauca, Colombia

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Not SpecifiedCompensation

Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, PharmaceuticalsIndustries

Requirements

Profesional en Ingeniería Biomédica, Química Farmacéutica o afines
Experiencia de mínimo 2 años en Industria Farmacéutica, con manejo de Sistemas de Calidad y Normativas locales e internacionales (p.e. GMP, Informe técnico 32, CCAA)
Inglés Intermedio/Avanzado
Manejo paquete Office y Power BI (Deseable)

Responsibilities

Asegurar el cumplimiento de las regulaciones locales e internacionales y normas aplicables (GMP, informe 32 OMS, resolución 1160 del 2016, resolución 4002 del 2007, Decreto 4725 del 2005 y normas ISO aplicables)
Asegurar el cumplimiento de las políticas corporativas, procedimientos locales y del manual de calidad y de todos aquellos relacionados con las operaciones de almacenamiento, acondicionamiento y distribución de los productos importados comercializados por Baxter
Asegurar el cumplimiento en la recepción técnica, inspección muestral cuando aplique, inspección de primero de código y liberación en el Sistema JD Edwards y WMS (Cuando aplique) de producto importado, incluyendo equipos biomédicos, dispositivos médicos y medicamentos
Asegurar el manejo con el 3PL en el proceso de producto no conforme, devoluciones, Hold, recall, discard, acondicionamiento, almacenamiento entre otras
Dar soporte en las auditorías internas y externas del área de aseguramiento de calidad centros de distribución
Dar soporte en el manejo adecuado de Hold en los centros de distribución de Colombia
Participar en las zonas de control de las bodegas, GEMBAS, monitoreo y seguimiento de indicadores propios del área
En ausencia del Supervisor de QA / Director Técnico, asumir la responsabilidad ante los entes regulatorios con alcance en dispositivos médicos importados manejados en las bodegas operadas por los 3PL (Operadores logísticos Salomia y Cortijo en Cali y Open en Bogotá)
En ausencia del Analista de Calidad Sr / Director Técnico, asumir la responsabilidad ante los entes regulatorios con alcance en Equipos Biomédicos importados manejados en la bodega operada por 3PL (Cortijo en Cali)

Skills

Key technologies and capabilities for this role

GMPISOJD EdwardsWMS3PLQuality ControlRegulatory ComplianceProduct ReleaseInspectionRecall Management

Questions & Answers

Common questions about this position

What is the employment type for this Analyst, Quality position?

The position is full time.

Is this a remote position or does it require on-site work?

This information is not specified in the job description.

What key responsibilities and skills are required for this role?

The role requires ensuring compliance with local and international regulations (GMP, WHO report 32, resolutions 1160/2016, 4002/2007, Decree 4725/2005, ISO norms), handling product reception, inspection, release in JD Edwards and WMS systems, managing non-conforming products with 3PL, supporting audits, and representing before regulatory entities for imported medical devices and equipment.

What is the company culture like at Baxter?

Baxter colleagues are united by a mission to Save and Sustain Lives, driven by a culture of courage, trust, and collaboration, where every individual is empowered to take ownership and make a meaningful impact, striving for efficient operations and accountability.

What makes a strong candidate for this Analyst, Quality role?

Strong candidates will have expertise in regulatory compliance for imported medical devices, biomed equipment, and pharmaceuticals in Colombia, experience with 3PL operations, quality systems like JD Edwards and WMS, and the ability to handle audits and regulatory responsibilities.

Baxter International

Provides essential medical products and services

About Baxter International

Baxter International provides a wide range of medical products and services essential for healthcare. The company operates in several areas, including critical care, hospital care, nutritional care, renal care, and surgical care. Its products are used in various settings, from emergency rooms to home healthcare, helping to meet the needs of patients and healthcare professionals. Baxter develops, manufactures, and distributes medical devices, pharmaceuticals, and biotechnology products, generating revenue through sales to healthcare providers and institutions. A key aspect that sets Baxter apart from competitors is its recent acquisition of Hillrom, which enhances its ability to offer comprehensive healthcare solutions. The company's goal is to improve care outcomes and increase access to healthcare through continuous innovation and a focus on patient needs.

Deerfield, IllinoisHeadquarters

1931Year Founded

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Health Insurance

Dental Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Parental Leave

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Commuter Benefits

Mental Health Support

Risks

Needle-free injection technology could disrupt Baxter's traditional injection-based therapies.

Shift to home healthcare may require Baxter to adapt its product offerings.

Growing digital health importance necessitates further investment from Baxter to stay competitive.

Differentiation

Baxter's acquisition of Hillrom enhances its comprehensive healthcare solutions portfolio.

Strong focus on patient-centric innovation sets Baxter apart in the healthcare industry.

Baxter's partnerships, like with Ayogo, leverage digital health for improved patient outcomes.

Upsides

Baxter's investment in Medically Home aligns with the growing home healthcare market.

Rising demand for personalized medicine offers Baxter opportunities for targeted therapies.

Expansion in telehealth supports Baxter's integrated healthcare solutions strategy.

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