Clinical Trial Label Compliance Associate

Keywords Studios•Indianapolis, IN

About The Position

The Clinical Trial Label Compliance Associate supports global clinical trial labeling by ensuring adherence to regulatory and quality system requirements. This role manages CAPAs, deviations, and change controls, and partners with labeling teams to investigate issues, identify root causes, and implement corrective actions. The associate helps maintain high quality standards and drives continuous improvement across labeling processes.

Requirements

Bachelor’s degree or associate degree and 5+ years of healthcare/pharmaceutical experience
Multi-tasking (will likely be tracking multiple change controls/deviations for broader organization)
High attention to detail
Able to work with businesses to foster quality culture.
Ability to work across functional areas with people of all levels of the organization.
Strong oral and written communication skills.
Ability to gather, edit, organize, and summarize information from multiple sources including databases, websites, site interviews, and audits.
Strong working knowledge of Excel, Word, PowerPoint, Change/Deviation Management System (Trackwise and/or OneQMS or similar), and QualityDocs or similar EDMS programs

Nice To Haves

Problem solver with strong self-motivation
Effective written and verbal communication skills
High initiative, flexible and positive attitude
Interpersonal skills to work in cross-functional and multicultural teams
Knowledge and experience working with QA in highly regulated area and relevant external experience, preferably within the industry, are highly beneficial.
Previous root cause analysis experience

Responsibilities

Proactively track and monitor all Change and/or Deviation Management System and related compliance commitment activities/due dates for the Clinical Trial Labeling organization. Provide communication and follow up throughout the organization to help ensure on-time completion.
Maintain open lines of communication with management, customers, and vendors to relay critical issues and improve turn-around times for CAPA, deviations and changes.
Create and enter observation records and change controls into Change/Deviation Management System.
Work with Clinical Trial Labeling team members, including quality, to assist/support completion of deviations and changes that support improvements to current processes, while ensuring adherence to timelines.
Create and maintain CAPA events and changes in Deviation Management System
Leverage project management skills to develop plans for change-controls and events, ensuring pro-active communications and on-time completion of events and changes
Develop and maintain CAPA expertise and Change/Deviation Management System knowledge
Lead and assist in identifying root causes when issues occur and develop, recommend, communicate, and implement corrective actions and lessons learned
Work across functional areas with individuals of all levels of the organization
Collect and report metrics
Identify root causes when issues occur and develop, recommend, communicate and implement corrective actions and lessons learned
Effectively plan for upcoming work and communicate to other groups (e.g., outsourcing, ELECTS), as needed
Collecting and reporting metrics
Coaching and mentoring of other less senior Label Management Associates
Manage change controls and track progress throughout the lifecycle