Regulatory Labeling Associate / Change Control Assistant

Artech Information System LLC; Spring House (PA); On-site; USD 65,000 - 85,000; Full time

Job summary

A leading IT staffing company is seeking a Regulatory Labeling Associate to support their Global Labeling Centre of Excellence. The role involves maintaining labeling change control records and improving data quality using the TrackWise system. Candidates should have a minimum of 2 years of experience in a regulated environment and strong MS Excel skills. Effective verbal and written communication in English is required. This contract position is pivotal for ensuring compliance and data integrity within the labeling process.

Qualifications

• Minimum of 2 years experience in a highly regulated environment.
• Knowledge of the TrackWise Change Control environment preferred.
• Effective communication skills in English.

Responsibilities

• Correct change control records in the Trackwise system.
• Set up and run reports in the Trackwise system.
• Manipulate data in MS Excel to identify gaps and issues.

Skills

Excel manipulation

Effective communication

Data analysis

Tools

TrackWise

MS Office

SharePoint

Job description

Regulatory Labeling Associate / Change Control Assistant

Contract

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.

Position Summary

This position is to support the Global Labeling Centre of Excellence (GL COE) Global Labeling Compliance (GLC) group with maintenance of labeling change control records within the TrackWise system to improve data quality and ensure timely completion of milestones.

Principle Responsibilities may include

• Correct change control records in the Trackwise system, in accordance with direction provided by GLC colleagues, following naming conventions and according to required timelines.
• Set up and run reports in the Trackwise system to assess data completeness of the records.
• Manipulate data in MS Excel to identify gaps and issues based on business rules.

Required Technical Competencies & Knowledge

• A minimum of 2 years experience in a highly regulated environment (pharmaceutical, etc.) required.
• Knowledge of and experience in the ETS Trackwise Change Control environment or equivalent preferred.
• MS Excel skills and comfort with MS Office and Sharepoint.
• Effective interpersonal, verbal and written communication skills, in English.
• Maintains confidentiality and meets own commitments.
• Completes work in a timely, error-free, and consistent manner.