Environmental Monitoring & Validation QA Assistant

Eurofins; Lancaster (Lancaster County); Presencial; USD 70.000 - 100.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Excellent medical, dental and vision

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Travel possible (10–25%)

Commuter benefits

Descripción de la vacante

Eurofins USA seeks a Quality Assurance Assistant for Environmental Monitoring & Facility Validation to support the network with quality systems, procedures, and training materials. The role emphasizes drafting SOPs, maintaining accreditation-related documents, and collaborating with site QA reps to capture service-line requirements.

You will engage in data integrity, regulatory compliance, and CAPA investigations while supporting EM equipment knowledge and cross-site quality initiatives.

Formación

• Bachelor’s degree in a scientific or quality-related field.
• 3+ years of experience in a GMP-regulated pharmaceutical, biotechnology, medical device, or laboratory environment.
• Experience with quality systems, SOP development, investigations, CAPAs, and training documentation.

Responsabilidades

• Draft, revise, and maintain environmental monitoring SOPs, work instructions, forms, and templates for review and approval, working to direction set by the Vice President, Environmental Monitoring.
• Assist with maintenance of quality documentation associated with laboratory accreditation and scope (e.g., ISO/IEC 17025, A2LA / ANAB), in support of site quality representatives.
• Collaborate with subject matter experts for service lines to capture technical requirements in procedures and training materials.
• Develop and maintain understanding of environmental monitoring equipment across the network to support quality and documentation requirements.
• Build and maintain environmental monitoring training content, competency assessments, and associated records in coordination with site quality representatives.
• Support data integrity requirements for EM field data capture, review, and reporting, including 21 CFR Part 11 and ALCOA+ principles.
• Assist site quality reps with investigations, deviations, CAPAs, change controls, and regulatory compliance documentation.
• Track quality initiatives, maintain records, and provide recommendations for process improvements.
• Escalate issues to the Vice President and take ownership of assigned quality workstreams.

Conocimientos

Quality systems

SOP development

CAPA investigations

Training documentation

Project management

Communication

Educación

Bachelor's degree in a scientific or quality-related field

Herramientas

LIMS

eQMS

Descripción del empleo

Eurofins USA seeks a Quality Assurance Assistant for Environmental Monitoring & Facility Validation to support the network with quality systems, procedures, and training materials. The role emphasizes drafting SOPs, maintaining accreditation-related documents, and collaborating with site QA reps to capture service-line requirements.

You will engage in data integrity, regulatory compliance, and CAPA investigations while supporting EM equipment knowledge and cross-site quality initiatives.