Quality Assurance Specialist

The Quality Assurance Specialist promotes an all-encompassing emphasis on quality through each phase of the research process. This position is responsible for establishing and maintaining systematic review of processes and documentation to ensure compliance with the FDA's Code of Federal Regulations, ICH Guidelines for Good Clinical Practice, as well as the HIPPA Privacy and Security Rules. The Quality Assurance Specialist's focus will center on measures to prevent, detect, investigate, assess, and correct errors and violations associated with the conduct of clinical trials.

To consistently embody AMR Clinical's Core Values:

• United We Achieve
• Celebrate Diverse Perspectives
• Do the Right Thing
• Adapt and Persevere

The QA Specialist will report directly to the Director of Quality Assurance.

Classification: Non-Exempt

Primary Responsibilities:

• Maintain and update the audit tracking tool to ensure information remains accurate and current.
• Support site staff during audits and inspections by regulatory agencies, sponsors, and/or contract research organizations (CROs).
• Assist with drafting and organizing audit/inspection response documents, escalating issues to senior QA staff as needed.
• Help develop and track Corrective and Preventative Action (CAPA) plans based on quality findings under the guidance of senior QA team members.
• Assist in determining whether a CAPA plan is needed and support investigations at the direction of QA management.
• Conduct CAPA plan follow-up activities, such as assigned review tasks, effectiveness checks, and assist in document findings according to the Quality Management Plan.
• Participate in internal audits by performing assigned review tasks and helping document findings according to the Quality Management Plan.
• Support risk-based document review, including protocols and study-related documents, by flagging potential issues for senior QA and site-level review.
• Assist sites by answering basic questions about protocol and study documents, escalating complex issues to senior QA personnel.
• Help ensure site compliance with SOPs, work instructions, and regulatory requirements through routine checks and documentation reviews.
• Support regular review of Informed Consent Form (ICF) processes by confirming proper use of approved versions and required steps.
• Collaborate with site staff to help address quality issues, escalating concerns appropriately.
• Review CRA reports for basic outstanding issues and communicate observations to the appropriate team members.
• Assist in tracking protocol deviations.
• Attend quality review meetings and prepare materials or updates, as assigned.
• Review site-specific processes to ensure alignment with SOPs and share observations with QA leadership.
• Identify potential SOP gaps and communicate suggestions to senior QA staff.
• Assist with creation and maintenance of training resources, contributing to training materials under direction of QA leadership.
• Perform other QA support duties as assigned, with an emphasis on learning and developing quality expertise.

Desired Skills and Qualifications:

• Foundational experience in clinical research, healthcare, or quality assurance; or successful completion of related training.
• Strong attention to detail, especially when handling documentation and compliance-related tasks.
• Ability to work independently on assigned tasks, while recognizing when to escalate issues.
• Good verbal and written communication skills, suitable for collaborating with site teams and documenting quality activities.
• Basic understanding of office software and tools, with the ability to earn specialized quality systems.
• Reliable follow-up and task management skills, ensuring deadlines are met and documentation is complete.
• Positive, supportive, and team-oriented mindset, contributing effectively in collaborative QA environments.
• Willingness to learn, take on new responsibilities, and grow within the quality assurance function.

AMR Clinical does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, retaliation, parental status, military service, or other non-merit factor.

** This job description is intended to be a representative summary of the major responsibilities and accountabilities of the staff holding this position. The staff may be requested to perform job-related tasks other than those stated in this description.

I have read the job description and acknowledge my key areas of responsibility.