ERT

GCP Compliance Analyst

Job Location US-PA-Philadelphia
Shift
Mon-Fri, 9-5
Type
Regular Full-Time

Overview

ERT Philadelphia is looking for a GCP Compliance Analyst to coordinate and manage assigned Quality Assurance GCP auditing and related Quality Management Systems activities and staff to ensure corporate compliance with regulatory authorities and industry expections. Inthis role you will ensure adequate quality monitoring procedures are implemented to proactively identify and resolve quality issues.

Responsibilities

 

  1. Under the supervision of the Manager GCP Compliance, support the execution of regulatory inspection activities to include coordination of resources, data or documents.

 

  1. Promote the Continuous Improvement program through management of issues to ensure accurate root cause analysis, corrective/preventive action implementation and confirmation of effectiveness. 

 

  1. Assist with the hosting and management of regulatory inspections for both ERT and ERT clients.  Analyze observations identified and generate effective responses.   Maintain associated QM system documentation.

 

  1. Assist with maintaining the Regulatory Inspection Library and the continued enhancement of the inspection process.  Assist with the development of tools to support inspection execution.

 

  1. Work collaboratively with all departments to assess, investigate and manage potential serious breaches of GCP as reported in the quality management system.

 

OTHER DUTIES AND RESPONSIBILITIES:

 

  1. Manage Issue Review Meetings as part of the Continuous Improvement Process and CAPA management.
  2. Provide consulting services to contracted external sources as required.

 

  1. Other duties as assigned.

 

 

The duties and responsibilities listed in this job description represent the major responsibilities of the position.  Other duties and responsibilities may be assigned, as required.  This job description and any attachments do not constitute or represent a contract.

 

 

 

Qualifications

 

  1. Bachelor's Degree
  2. 1-3 years’ experience in a regulated environment, preferred experience in QA/RA
  3. Experience supporting audit activities, regulatory inspection support a plus.
  4. Knowledge of ICH GCP, 21CFR Part 11, 21 CFR 820.20, ISO 9001, ISO 13485 and applicable regulatory authorities or experience in a highly regulated industry.
  5. Excellent leadership, analytical, organizational and communication skills
  6. Detail oriented.

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.

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