Quality Systems Specialist, Environmental Monitoring

Energy Jobline ATTB; Us; On-site; EUR 53,000 - 76,000; Full time

Benefits offered by this job

Medical coverage

Dental & Vision

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins USA BioPharma Services seeks a Quality Assurance Assistant to support Environmental Monitoring and Facility Validation programs across its US laboratory network. The role focuses on quality systems, documentation, and training materials, collaborating with site quality representatives and SMEs.

You will draft procedures, maintain records, ensure data integrity, and assist with audits and regulatory compliance, including ISO 17025 and 21 CFR Part 11, with room to grow into broader

Qualifications

• Bachelor's degree in a scientific or quality-related field.
• 3+ years of GMP-regulated pharma/biotech/lab experience.
• Experience with quality systems, SOPs, investigations, CAPAs, and training docs.
• Familiarity with eQMS, LIMS, and regulatory requirements.
• Strong organization, communication, and project-management skills.
• Ability to manage multiple priorities and travel as needed.

Responsibilities

• Draft, revise, and maintain environmental monitoring SOPs and templates.
• Assist with quality documentation for ISO/IEC 17025, A2LA/ANAB accreditation.
• Collaborate with SMEs to capture requirements for each service line.
• Develop training content and competency assessments for EM.
• Support data integrity and 21 CFR Part 11 compliance.
• Assist with investigations, CAPAs, deviations, and change controls.
• Track quality initiatives and prepare summaries for leadership.
• Ensure GMP/GLP compliance and incorporate new sites into EM quality systems.

Skills

GMP/GLP knowledge

Documentation

Project coordination

Regulatory compliance

Education

Bachelor's degree in scientific/quality field

Tools

eQMS

LIMS

Environmental monitoring equipment

Job description

Eurofins USA BioPharma Services seeks a Quality Assurance Assistant to support Environmental Monitoring and Facility Validation programs across its US laboratory network. The role focuses on quality systems, documentation, and training materials, collaborating with site quality representatives and SMEs.

You will draft procedures, maintain records, ensure data integrity, and assist with audits and regulatory compliance, including ISO 17025 and 21 CFR Part 11, with room to grow into broader