Quality Lab Associate III - Sterility Assurance Empleos

Quality Lab Associate III - Sterility Assurance

Baxter

Ubicación:
United States , Marion

Categoría:
Control de Calidad

Tipo de contrato:
No proporcionado

Salario:

80000.00 - 110000.00 USD / Año

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Descripción del trabajo:

Subject Matter Expert on qualifications related to Environmental Monitoring program and Contamination Control from the microbiological standpoint. Responsible for completion of room qualifications of controlled manufacturing areas. Responsible for completion of assessments to determine impact on the microbiological conditions related to manufacturing clean rooms.

Responsabilidades:

Author and complete Environmental Monitoring Performance Qualifications (EMPQ) related to the manufacturing clean/classified rooms in compliance with local and regulatory requirements
Coordinate sampling activities with EM sampling team and manufacturing department as applicable
Perform Failure Modes and Effects Analysis, as needed
Prepare and present to management the trend reports related to EMPQ and contamination control activities
SME of EMPQ and contamination control aspects providing leadership, technical and quality support to manufacturing and during regulatory inspections or site audits
Understands and assures conformance to regulations
Works with regulators during regulatory inspections
Interacts frequently with functional peer group and managers, as appropriate
Identifies and leads continuous improvement projects with the objective of achieving quality, reliability, and cost improvements
Sustain a clean and safe work area using 6S principles
Learn, understand, and apply thorough quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP). Author and revise Standard Operating Procedures as needed.
Review and approve EMPQ and contamination control procedures, protocols, and reports
Perform Sterility Assurance Assessments as part of the Change Control Management process
Assist in establishing response plans to environmental out of limits
May be asked to lead classroom-based training for new employees and continuous education classes for established employees

Requisitos:

BS degree in Biology or Microbiology
Five (5) or more years of professional experience in Laboratory, Quality, Manufacturing, or related field is strongly preferred
Strong understanding of Environmental Monitoring programs, Microbiology concepts and Good Documentation practices is preferred
Detailed knowledge of applicable procedures, specifications, regulations, and standards
Strong analytical and problem-solving skills
Ability to run multiple projects/investigations/priorities
Good communication and leadership skills
Good interpersonal/communication/influencing/negotiation skills
Good project management skills
Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings
Strong technical written skills
Knowledge of TrackWise Quality Management System

Lo que ofrecemos:

Medical, Dental and Vision coverage
160 hours of Paid Time Off and Paid Holidays
401K match
Employee Stock Purchase Program
Paid Parental Leave
Tuition Reimbursement

Información adicional:

Oferta publicada:
18 de enero de 2026

Tipo de empleo:

Tiempo completo

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Quality Lab Associate III - Sterility Assurance

Baxter

Ubicación:
United States , Marion

Categoría:
Control de Calidad

Tipo de contrato:
No proporcionado

Salario:

Descripción del trabajo:

Responsabilidades:

Requisitos:

Información adicional:

Oferta publicada:
18 de enero de 2026

¿Buscas más oportunidades? Busca otras ofertas de trabajo que coincidan con tus habilidades e intereses.

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Quality Lab Associate III - Sterility Assurance

Baxter

Ubicación:United States , Marion

Categoría:Control de Calidad

Tipo de contrato:No proporcionado

Salario:

Descripción del trabajo:

Responsabilidades:

Requisitos:

Información adicional:

Oferta publicada:18 de enero de 2026

¿Buscas más oportunidades? Busca otras ofertas de trabajo que coincidan con tus habilidades e intereses.

Empleos similares para Quality Lab Associate III - Sterility Assurance

Coordinador/a Proyectos de Inspección

Coordinador de Compras

Personal de supermercado

Personal de supermercado

Personal de supermercado

Vendedor/a

Vendedor/a Tiempo Parcial

Líder De Equipo, Servicios Médicos

Ubicación:
United States , Marion

Categoría:
Control de Calidad

Tipo de contrato:
No proporcionado

Oferta publicada:
18 de enero de 2026