Clinical Trial Label Compliance Associate

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.

Key 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

Additional responsibilities may include

• 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

Requirements

• Bachelor’s degree or associate degree and 5+ years of healthcare/pharmaceutical experience
• Manage change controls and track progress throughout the lifecycle
• 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

Preferred

• 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

Benefits

KeyWords provides all its contingent workforce with

Medical, dental and vision benefits

Paid time off (including sick and select holidays)

401(k) enrollment with 3% employer matching

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law

Role Information: EN

Studio: Keywords Studios

Location: Indianapolis, IN

Area of Work: Label Management

Service: Manufacturing

Employment Type: Contractor

Working Pattern: Full Time

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COMPANY PROFILE

Established in 1998 and floated on the London Stock Exchange’s AIM in 2013, Keywords(KWS) is the world’s leading provider of technical and creative services to the global video games market. Our 12,000 employees in 70+ Studios in 26 countries provide graphic art asset production, game development, audio, testing, localization and customer support services to most of the leading video game developers and publishers. We have a proven track record of organic and acquisition-led growth and have successfully acquired and integrated 50+ acquisitions since 2014.

WHY WORK AT KEYWORDS STUDIOS?

People who work at Keywords are passionate, talented, committed and resourceful. As a business we thrive on diversity, celebrate uniqueness and work as teams whether we are physically together in one of our 70 global studios or working together virtually.

We empower people to perform to the best of their ability with our “can do” attitude. We appreciate and embrace flexibility. We learn at every opportunity to grow ourselves through experience, training and tackling new challenges.

This is what makes us Keywordians.

https://www.keywordsstudios.com/