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Quality Systems Documentation System Administration Specialist II 9/15/2016

Shire Pharmaceutical Chesterbrook, PA

Company
Shire Pharmaceutical
Job Classification
Full Time
Company Ref #
14650BR
AJE Ref #
576181356
Location
Chesterbrook, PA
Experience
Mid-Career (2 - 15 years)
Job Type
Regular
Education
Bachelors Degree

JOB DESCRIPTION

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Job Description
PRIMARY ROLE:
Provide system administration for the MasterControl Electronic Document Management System for Technical Operations.
SME/contact for systems administrating globally and will interact with regulatory inspectors, and external customers. This functional role must partner globally, establishing strong relationships with vendor, IT, R&D and others to ensure an efficient process.

RESPONSIBILITIES:
MasterControl System Administration (60-70%)
Process user access requests and other routine system administration requests in a timely matter. Manages workloads and make decisions related to prioritization.
Manage and respond to System Administration Help Desk Tickets in order of receipt and priority, using system knowledge of MasterControl, independent troubleshooting experience, knowledge of the documentation process and connecting processes such as the training process.
o Communicate clearly and effectively with internal customers during troubleshooting, solution finding and proposal, and final resolution.
o Propose and work with Sr. Systems Administrator to implement compliant and efficient solutions.
o Effectively escalate System related IT issues to IT and MasterControl as appropriate. Follow through to resolution.
Support migration activities for the system expansion, including development of import spreadsheets, verification of data, and post migration confirmations
Participate in Integration projects from a MasterControl system administration perspective
Establish a process for in-taking, prioritizing, assessing, and implementing system improvement and system change requests. Assists with system improvements by work with IT and other functional groups to prioritize and implement system improvement and changes. Execute system improvements including draft system Change Requests as needed and other system administration work
Work closely and effectively with Quality Document Management team, and other process owners who own connecting systems such as training system, IT and other MasterControl Administrators from other functional areas.
Training and Support (~20%)
Develops and supports user training for MasterControl
Supports MasterControl SME forums as needed
Identify and provide other education, tools and tips for users
Works with other MasterControl Administrators to ensure consistency across organization, and to ensure that system change impacts to Tech Ops Documentation process and connecting systems/processes are assessed.
Files and archives system records as required.
Work with Sr. Documentation Archival personnel as required for filing and archiving of quality records.

Improvements and Projects
Participate in quality and process improvement initiatives and project teams.
Provide support for internal/external audits/and inspections. May interact directly with inspectors.
May own and lead deviation investigations and CAPAs within scope

EDUCATION & EXPERIENCE REQUIREMENTS:
Essential:
B.S. in sciences, engineering or equivalent
Requires a minimum of 3 years previous experience working in a cGMP/GXP environment.
Previous System Administration experience in a GxP environment.
Has knowledge of practical applications of Records and Document Management with a broad understanding of 21 CFR parts 210 & 211 Parts 4, 11 and 820 and EU regulations.
High level of proficiency with MS Office, including Word, Excel and Power Point and ability to learn new systems.
Highly organized and detail oriented

Desired:
Knowledge of continuous improvement principles and practices such as six sigma methodologies to include process mapping and evaluation preferred.
System Administration experiences in a Document Management System.
MasterControl experience

OTHER JOB REQUIREMENTS:
Represent department to internal customers.
Work directly with external vendors, customers, and consultants.
Represents organization on projects.
Interact with regulatory inspectors

ABOUT SHIRE:
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.

EQUAL EMPLOYMENT OPPORTUNITY
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

EEO is the Law
EEO is the Law - Supplement
Pay Transparency Policy

Reasonable Accommodations
Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.