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Job Title: Direct Hire - GMP Document Control Coordinator
Work Location: Baltimore, MD
Remuneration: Lucrative Salary+Excellent Benefits+Annual Bonus
Client: A Big Pharmaceutical Company
Interview Process: First Phone Screening then Onsite
This position is responsible for the execution, maintenance and improvement of the document management and GMP training programs at Client 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.
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 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 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 Baltimore/Gliadel production and/or operational activities 10%
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.
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
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.
Interested candidates can share their most updated resume at firstname.lastname@example.org or they can reach out to me on #973-967-3412
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