Remote Fda Auditor Jobs Near Me

We are seeking a QA Specialist - Virtual Hub to support the Quality Assurance Team within the Call Center.

Position Summary

The QA Specialist ensures day-to-day quality oversight of the virtual HUB, with a focus on internal auditing, call quality monitoring, QA data analysis, and case review. You'll partner with Operations, Compliance, and Case Management teams to maintain a robust QMS, drive compliance with quality assurance expectations, and enable safe, right-first-time case handling.

Key Responsibilities

Internal Audit (~30%)

• Plan, execute, and report risk-based internal audits of case intake, storage, documentation, program SOP handling, record handling, and case closure.
• Track observations, grade findings, and drive CAPA effectiveness through to verified closure.
• Trend audit data, prepare dashboards/metrics, and present results in quality reviews and readiness checks.
• Collaborate with multiple teams to improve call center KPIs and general metrics

Call Quality & QA Data (~30%)

• Assists in the development of monitoring standards.
• Monitor and score calls using automated speech analytics and manual review against the QA scorecard, covering compliance, service, and process adherence.
• Calibrate automated scoring against human review to confirm accuracy and consistency across agents and programs.
• Analyze QA data trends by agent, team, program, and call type to identify systemic risks and coaching opportunities.
• Build and maintain QA dashboards/reporting for leadership visibility into call quality performance.
• Works directly with leadership to drive process improvements within the team

QA in Case Handling (~25%)

• Provide real-time QA oversight (documentation verification, record checks, case review, and process adherence checks).
• Coach teams on quality behaviors; support training, change control, and document control.
• Participate in deviation/incident investigations; perform root cause analysis and implement systemic fixes.

CAPA Management (~15%)

• Own the CAPA process: intake, evaluation, disposition, and documentation.
• Coordinate with Compliance and Program teams; ensure root cause resolution and effectiveness verification.
• Support/coordinate CAPA trending: analysis, tracking, notifications, execution, and effectiveness checks.

Qualifications

• 2–5 years in Quality Assurance within a call center, pharmacy operations, patient support programs, or related environment.
• Working knowledge of applicable Board of Pharmacy and FDA requirements as they relate to patient-facing calls.
• Hands-on experience with call quality monitoring, QA scorecards, and CAPA/deviation investigations.
• Experience with speech analytics platforms (e.g., CallMiner or similar) and a QMS/eQMS (e.g., Dot or similar).
• Strong data fluency; comfortable building and interpreting QA trend reports and dashboards.
• Zendesk or comparable ticketing/case-management platform experience for issue intake, triage, and documentation.
• Strong attention to detail; clear written/verbal communication; ability to influence cross-functionally under time pressure.

Desired Attributes

• CPhT or state Pharmacy Technician license; RAC, ASQ CQA, or similar quality certification.
• Experience with complaint/PQC intake and documentation practices.
• Familiarity with scope-of-practice enforcement and escalation protocols in a call center setting.
• Prior work in a pharmacy call center, patient support, or program services environment.

Work Environment

• Location: Remote
• Schedule: Full-time
• May require additional availability or flexibility for audits or investigations.
• Regular meetings with teams, departments, or leadership to ensure alignment.

Equal Employment Opportunity (EEO) Statement

Gifthealth is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions are made without regard to race, color, religion, sex, sexual orientation, gender identity, transgender status, national origin, age, disability, veteran status, or any other legally protected status.

Disclaimer

This job description is intended to describe the general nature and level of work being performed. It is not intended to be an exhaustive list of all responsibilities, duties, or skills required of personnel.Gifthealth reserves the right to modify job duties or descriptions at any time.