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GMP Document Control Coordinator
Ref No.: 18-25485
Location: Baltimore, Maryland
Job Title: Direct Hire - GMP Document Control Coordinator
Location: Baltimore, MD 21224
Employment Type: Dire Hire – Permanent Position
 
Notes from Hiring Manager:
  • Must have a minimum of three years in a documentation control position
  • Individuals who were previously managers likely will not fit well...this is a staff level role
  • Candidates should be local to Baltimore as there is no relocation for this role
 
Description:
 
Summary
  • This position is responsible for the execution, maintenance and improvement of the document management and GMP training programs at Client's Baltimore
  • The person in this position will serve as subject matter expert and site coordinator for Document Control and Training systems.
  • Incumbent will demonstrate effective teamwork by developing strong relationships with internal customers, peers and management through effective oral and written communication in a GMP environment
  • Given their level of GMP/technical knowledge and experience, this position will work independently with minimal management direction.
 
Essential Functions
Responsibilities Percent of Time
The primary responsibility for this position is to administer and maintain the following quality systems in compliant and efficient manner: 60%
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 30%
  • Develop schedule for all GMP training at Client's Baltimore; 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 Client's Baltimore 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 Client's production and/or operational activities 10%
 
Scope Measures
  • The position manages the Document Control and Training systems for the site. This person evaluates the compliance of records, documents, and quality system to ensure that the site is operating per cGMP requirements as well as interprets and applies cGMPs, regulatory guidance and directives. This person also exercises independent judgment in evaluating compliance.
 
Knowledge/Skills/Abilities Required
 
Education and Experience
  • 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 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