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About the Role
Assist in the development and maintenance of the organization’s Quality Management System (QMS), including incident management, audit management, systems validation, and electronic QMS (eQMS) administration. This role supports the QA team in managing and improving the QMS and eQMS to meet organizational needs.
Responsibilities
- Assist in cross-office compliance efforts.
- Work with office leaders to define compliance needs.
- Conduct assessments (IAPs) and/or Gap Assessments.
- Build, enforce, and improve QMS infrastructure.
- Participate in regular meetings with QA personnel.
- Ensure success of current quality initiatives by working with a cross-office team.
- Assist with incident management, CAPA management, and eQMS implementation.
- Perform system administrator duties in the eQMS.
- Conduct internal audits and recommend procedure improvements.
- Conduct investigations into incidents of noncompliance.
- Track, monitor, and gather metrics from corrective and preventative action activities.
- Provide support to other QA team members and Project Leads.
- Assist with eQMS quality software validation efforts, including documentation and testing.
- Maintain knowledge of regulations, trends, and 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.
- Create and revise documentation related to company or department policies, procedures, workflows, and guides.
- Review, proofread, and edit business correspondence.
- Assist in business development initiatives as necessary.
Requirements
- Familiarity with general clinical trial best practices for data management and Good Clinical Practice (GCP) guidelines.
- Experience in systems administration.
- Familiarity with Federal regulations affecting clinical trial data management work such as relevant FDA regulations and 21 CFR Part 11.
- Ability to work independently while managing a large number of competing deadlines.
- Ability to read and comprehend industry literature, especially for quality assurance and general compliance topics, and to conduct research to facilitate answers to compliance inquiries.
- Strong writing skills and the ability to produce documentation using proper English and grammar.
- Excellent communication and interpersonal skills, along with the ability to facilitate discussion and gather information.
Skills
- Quality Management System (QMS)
- Incident Management
- Audit Management
- Systems Validation
- Electronic QMS (eQMS)
- System Administration
- CAPA Management
- Internal Audits
- Technical Writing
- Documentation
- Policy and Procedure Development
- GCP
- FDA Regulations
- 21 CFR Part 11
Location
- Amherst, NY
- Remote
Work Type
- Remote
- Onsite
Experience Level
- 0-2 years of relevant experience
Education Level
- Bachelors’ degree required
About the Company
- Frontier Science is a mission-driven organization dedicated to advancing scientific research and public health.
Equal Opportunity
- All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, national origin, disability, age, or veteran status.