Regulatory Labeling Associate

Artech Information System LLC; Spring House (PA); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading IT staffing firm in Pennsylvania is seeking a skilled professional to support the Global Labeling Compliance group. This role involves maintaining change control records in the Trackwise system, ensuring data quality, and utilizing MS Excel for data manipulation. Candidates must have at least 2 years of experience in a regulated environment and possess strong communication skills. This position offers the opportunity to enhance your expertise in a critical compliance role.

Qualifications

• A minimum of 2 years’ experience in a highly regulated environment (pharmaceutical, etc.).
• Knowledge of the ETS Trackwise Change Control environment or equivalent preferred.
• Effective interpersonal, verbal and written communication skills in English.

Responsibilities

• Correct change control records in Trackwise as directed by GLC colleagues.
• Set up and run reports in Trackwise to assess data completeness.
• Manipulate data in MS Excel to identify gaps and issues.

Skills

Experience in a highly regulated environment

Knowledge of Trackwise Change Control

MS Excel skills

Effective communication skills

Tools

MS Excel

MS Office

Sharepoint

Job description

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.

Job Description

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.

Job Responsibilities

• 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.

Qualifications

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.