GMP Document Control Coordinator

Title: GMP Document Control Coordinator

Location: Baltimore MD (commutable candidates only please)

Direct Hire Role

 

Qualified Candidates MUST have a minimum of 3 years’ experience in document management, and training administration within a regulated Pharmaceutical environment

 

The role:

This position is responsible for the execution, maintenance and improvement of the document management and GMP training programs for this site. The person will serve as a subject matter expert and site coordinator for Document Control and Training systems.

 

The primary responsibility for this position is to administer and maintain the  following quality systems in a compliant and efficient manner:

1) Document Control – includes, but not limited to:

  • Generate and issue site-specific GMP associated documents as required to support the production function
  • Coordinate the final review, revision, approval and issuance for all site-specific GMP associated documents
  • Maintain current versions of site-specific GMP associated documents on the site on-line index
  • Maintain all documentation related to new, revised and retired items  on the Material Parts List
  • Conduct routine Parts List audits
  • Coordinate site specific document shipments for client reference or for off-site storage and/or retrieval
  • Prepare and provide documentation as required for internal and  regulatory agency audits and maintain copies of reviewed documents
  • Conduct periodic document audits and assist with internal audits of  the QA and/or document management functions
  • Manage Offsite storage and retrieval of the documents
  • Perform/Assist with record retentions duties in support of the established record retention procedures/policies

 

2) Quality Training and Corporate Learning Management (LMS) systems

  • Develop schedule for all GMP training at site; coordinate all activities related to these sessions
  • Evaluate effectiveness of training components and overall program
  • Maintain comprehensive matrix of employee GMP training requirements
  • Maintain training records (paper and/or electronic) for all site employees as well as contractors and/or consultants
  • Review documentation contained in GMP employee training records for compliance
  • Provide reports to management as necessary

 

3) Other QA duties as assigned to facilitate ongoing site production and/or operational activities

 

 

REQUIRED EXPERIENCE AND EDUCATION
· Bachelor’s degree preferred; minimum 2 years relevant secondary education required
· Must have a minimum of 3 years’ experience in document management, and training administration within a regulated Pharmaceutical environment

Technical
· Working knowledge of GMP related Quality Systems
· Strong attention to detail as demonstrated through consistent quality of work
· Excellent written and verbal communication skills
· Computer proficiency in MS Word and Excel, Lotus Notes, MS Access required; previous administrative experience in electronic learning management systems (LMS) preferred 
· Demonstrates process orientation—thinks through required steps and sequencing to ensure quality work output
· Ability to anticipate potential problems and take proactive action to avoid/minimize impact
· Anticipates consequences of actions and how they impact other areas
· Ability to independently prioritize, plan and schedule workflow
· Timely follow up to ensure satisfactory resolution to issues
· Knowledge of CGMPs (relevant laws, guidance, directives and industry practice), and demonstrated ability to apply learnings appropriately
· Ability to work and coordinate activities across multiple functional groups with a sense of professionalism and urgency
· Self-motivated; able to work with minimal supervision
· Ability to work in a controlled environment
· Excellent Organizational skills, attendance and reliability required

  • Accepted file types: doc, pdf, txt, docx.