Clinical Trial Labeling Compliance Specialist

Work Hours: Monday-Friday, 8am-5pm

Pay rate: $24/hr

The Clinical Trial Labeling organization team is responsible for providing Investigational Product labeling for global clinical trials in all development phases that meets the needs of a given study and are compliant with all applicable regulatory requirements. The CT Label team partners with other Clinical Supply and Delivery teams and provides oversight of business processes related to phrase translations, Regulatory requirements, and label creation and approvals.

The Clinical Trial Labeling Compliance Specialist will interact and communicate with the Clinical Trial Labeling teams, leverage project management skills to manage CAPA (Corrective and Preventive Actions) changes and events, change controls, deviations, and other compliance related activities within the Change/Deviation Management system. In addition, they will aid Clinical Trial Labeling teams to help ensure that our processes and quality systems are well managed and when breakdowns occur, we aggressively evaluate and provide corrective and preventative actions. The Clinical Trial Labeling Compliance Specialist is responsible for providing Deviation Management System support for the Clinical Trial Labeling team, including assistance with investigations and root cause analysis and proactive communications on upcoming CAPA deliverables. The Clinical Trial Labeling Compliance Specialist helps to ensure that the Clinical Trial Labeling function maintains the highest quality standards and complies with regulations and quality system requirements.

Keywords provides a competitive compensation package, good benefits and a casual, fun, productive and supportive working environment. We empower people to perform to the best of their ability with our “can do” attitude. We appreciate and embrace flexibility and learn at every opportunity to grow ourselves through experience, training and tackling new challenges. This is what makes us Keywordians.

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

Requirements

Manage change controls and track progress throughout the lifecycle

Multi-tasking (will likely be tracking multiple change controls/deviations for broader organization)

Diligent attention to details & organization skills

Able to work with the business to foster a 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

Other preferences:

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