Quality Systems Specialist – Environmental Monitoring

SmartRecruiters, Inc.; Lancaster (Lancaster County); On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

Medical, dental, vision

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins USA BioPharma Services in Lancaster, PA seeks a Quality Assurance Assistant to support Environmental Monitoring and Facility Validation across the US network.

You will develop and maintain SOPs, training materials, and quality documentation, ensure data integrity under 21 CFR Part 11, and work with site quality reps and SMEs.

This growth role offers full-time hours, travel 10–25%, benefits, and opportunities to expand network-wide quality systems expertise.

Qualifications

• Bachelor's degree in a scientific or quality-related field.
• 3+ years in a GMP-regulated pharma/biotech/lab environment.
• Experience with quality systems, SOPs, investigations, CAPAs, and training docs.
• Familiarity with eQMS and LIMS; knowledge of regulatory requirements.
• Strong organizational, communication, problem-solving, and project management skills.

Responsibilities

• Draft, revise, and maintain EM SOPs, work instructions, forms and templates.
• Maintain quality documentation for accreditation and scope (ISO/IEC 17025, A2LA / ANAB).
• Collaborate with SMEs to capture service-line requirements in procedures and training materials.
• Support data integrity and 21 CFR Part 11 and ALCOA+ principles.
• Assist with investigations, deviations, CAPAs, and change controls.
• Track quality initiatives and propose process improvements.
• Escalate issues to VP for Environmental Monitoring.

Skills

Quality systems experience

SOP development

Investigations & CAPAs

Project management

Communication skills

Education

Bachelor's degree in scientific or quality field

Tools

eQMS

LIMS

Job description

Eurofins USA BioPharma Services in Lancaster, PA seeks a Quality Assurance Assistant to support Environmental Monitoring and Facility Validation across the US network.

You will develop and maintain SOPs, training materials, and quality documentation, ensure data integrity under 21 CFR Part 11, and work with site quality reps and SMEs.

This growth role offers full-time hours, travel 10–25%, benefits, and opportunities to expand network-wide quality systems expertise.