QA & Compliance Specialist I - eQMS & GCP Focus

Frontier Science; Town of Amherst (NY); On-site; USD 45,000 - 55,000; Full time

Job summary

Frontier Science in Amherst, NY is seeking a Quality Assurance Specialist I to help develop and maintain the organization’s Quality Management System (QMS) and eQMS. You will support incident management, audits, and system validation, working with QA colleagues to ensure compliant, reliable processes across the organization.

The role requires a Bachelor’s degree and up to 2 years of relevant experience, plus familiarity with GCP and FDA regulations (21 CFR Part 11).

Qualifications

• Bachelor's degree required.
• 0-2 years of relevant experience.
• RQAP Certification preferred.
• Familiarity with GCP and FDA regulations.
• Experience in systems administration.
• 21 CFR Part 11 familiarity.
• Ability to manage multiple deadlines independently.
• Strong writing and documentation skills.
• Excellent communication and interpersonal skills.

Responsibilities

• Assist in cross office compliance efforts.
• Work with office leaders to define compliance needs.
• Conduct assessments and/or gap analyses.
• Build, enforce and improve QMS infrastructure where required.
• Regular meetings with QA personnel in Amherst and other offices.
• Ensure success of current quality initiatives by working with a cross office team of QA experts.
• Assist with incident management, CAPA management, and eQMS implementation.
• Performs system administrator duties in the eQMS.
• Conduct internal audits and recommend procedure improvements as needed.
• Track, monitor, and gather metrics from corrective and preventative action activities.
• Provide support to other QA team members and Project Leads.
• Assist with the eQMS quality software validation efforts, including preparing the required documentation and testing efforts.
• Maintain knowledge and expertise in regulations, trends, and industry best practices affecting the clinical research GCP environment.
• Train other office staff on the organization’s eQMS and associated policies and procedures.
• Assist in writing policies and procedures for the Quality Department.
• Assist with technical writing activities as needed.

Skills

Strong writing skills

Excellent communication

Interpersonal skills

Independent worker

Education

Bachelor's degree

Job description

Frontier Science in Amherst, NY is seeking a Quality Assurance Specialist I to help develop and maintain the organization’s Quality Management System (QMS) and eQMS. You will support incident management, audits, and system validation, working with QA colleagues to ensure compliant, reliable processes across the organization.

The role requires a Bachelor’s degree and up to 2 years of relevant experience, plus familiarity with GCP and FDA regulations (21 CFR Part 11).