My Shortlist

Your shortlisted jobs will appear here. To view your shortlist, please login or register

More Jobs Like This
DATE ADDED: Wed 20/11/2019

GMP Document Control Coor.2802

Baltimore, MD, US


JOB TYPE: Permanent, FullTime

Job Description:

This position is responsible for the execution, maintenance and improvement of the document
management and GMP training programs at Eisai 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

* 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 Eisai 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 Eisai 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 Eisai Baltimore/Gliadel 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


* 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

Please send resume to #removed#

*City:* Baltimore

*State:* MD