ERT

Document and Training Compliance Specialist

Job Location US-PA-Philadelphia | US-NY-Rochester | US-PA-Pittsburgh | US-OH-Cleveland
Shift
Regular
Type
Regular Full-Time

Overview

ERT is looking to hire a Document and Training Compliance Specialist. In this role you will promote interdepartmental collaboration by partnering with departments to facilitate corporate compliance objectives related to document management and training compliance. You will lead initiatives that support the team's ability to deliver high quality systems, execute efficient processes, and develop appropriate tools that will enhance team performance.

Responsibilities

 

  1. Lead departmental efforts related to systems, processes, or tools to enhance team performance and maximize the ability to better serve the organization.
  2. Develop interdepartmental relationships to support departments and achieve corporate compliance measures.
  3. Support the company’s departmental training programs and training documentation records through the administration of ERT’s document management system, in accordance with standard operating procedures.
    1. Document and maintain current training programs for all department positions per the direction of department management.
    2. Review all training records submitted for completeness and formatting accuracy.
    3. Administer the document management system application to:
      1. Maintain an up-to-date user list.
      2. Track employee required training.
  • Issue training activities to employees according to their company position and associated training requirements.
  1. Run reports to monitor employee training deficiencies.
  2. Manage all employee CVs and Signature Logs according to standard operating procedures and make them available upon request.
  3. Support the triennial job description review process.
  1. Support maintenance of the company’s quality system documents through the administration of the document management system, in accordance with standard operating procedures.
    1. Ensure that all quality system documents are maintained in compliance with regulatory authorities and internal standards.
    2. Implement procedures to ensure consistent maintenance of all quality system documents held in the document management system
    3. Maintain systems to accurately track and retrieve documents upon request.
    4. Perform reviews of quality system documents for completeness and formatting accuracy.
    5. Provide regular compliance and SOP status reports of central file contents through the use of document-tracking database.
    6. Administer the document management system application to:
      1. Run reports to monitor biennial review schedules
      2. Provide documentation of review according to standard operating procedures.
    7. Complete the archiving of quality system documents as required.

 

  1. Provide appropriate document management system training for company personnel.
  2. Serve as local on-site/service line specific support for organizational document and training compliance needs.

 

 

OTHER DUTIES AND RESPONSIBILITIES:

 

  1. Support the implementation of new/revised data systems, technologies, and methods to improve ERT services or support Operation expansion. This includes:
    1. Participating in systems implementation teams.
    2. Establishing User Requirements.
    3. Conducting test scripts and ad hoc testing.
    4. Creating system SOPs and developing manuals and training materials.
    5. Completing all necessary training and competency testing.
  2. Assist departments, when requested, with collection, organization and management of documentation to support the QA department.

 

 

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.  ERT reserves the right to amend or change this job description to meet the needs of ERT.  This job description and any attachments do not constitute or represent a contract.

Qualifications

Education:

 

  • Bachelor Degree or equivocal experience required.

 

Experience:

 

  • 2-4 years of experience in pharmaceutical field (or related industry experience)
  • Knowledge of the pharmaceutical drug development process and CPMP guidelines.
  • General knowledge of pharmaceutical regulatory practices as they pertain to use of electronic data collection and results reporting.
  • Excellent communication, customer service, problem solving, and organizational skills.

Ability to lead and influence without direct authority.

 

Other:

 

  • Ability to travel up to 10%

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