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Quality Document Management Specialist 1

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POST DATE 9/13/2016
END DATE 12/22/2016

Shire Pharmaceutical Lexington, MA

Lexington, MA
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Mid-Career (2 - 15 years)
Bachelors Degree


Job Description
The Quality Document Management Specialist is an individual contributor. This individual will conduct day to day quality documentation processing in support of ongoing projects and daily GMP/GDP operations. . Will enhance and maintain quality documentation processes and systems for cGMP/GDP documents. Will provide support to internal end users on for document management processes and associated systems globally, establishing strong relationships to ensure an efficient process.

Day to day quality documentation processing in support of ongoing projects and daily GMP/GDP operations (80%):
Scope including, but not limited to; SOP s, Batch Records, Material Specifications, Product Specifications, and Formulation Preparation Sheets
Assess documentation packages against applicable procedures, processes and guidelines. Make edits and review comments to provide to partners globally to ensure compliance. Make document processing decisions to ensure compliance to established expectations
Maintaining filing/ documentation repositories
Coordinating and assisting with global regions with translation
Coordinating and assisting managers and document owners with biennial review.
Coordinate with sites and regions to prepare and maintain the user books as needed.
Assess impacted documents and associated documents.
Archival of GMP Records and coordination of Archival activities with Manufacturing groups.
Generate revision history as needed.
Balance workloads and make decisions related to prioritization.

Support and advice end users on document system requirements and workflows.
Evaluate issues received from end users, make decision on appropriate follow-up steps based on established processes, procedures and guidelines, make decision on escalation to manager as appropriate.
Enhance and maintain documentation control processes and systems
o Identify opportunities for process and system improvement and enhancement
o Participate in quality and process improvement initiatives and project teams.
o Participate in Integration projects from a document control perspective.
o Provide support for internal/external audits/and inspections.
o May assist with documentation metrics reporting.
May contribute to deviation investigations and CAPAs within scope.

B.S. in scientific discipline or equivalent.
Requires a minimum of 2 years previous experience in document management working in a cGMP/GXP environment. Experience in Document Management.
Has knowledge of practical applications of Document Management and cGMP.
Proficiency with MS Office, including Word, Excel and Power Point, Adobe and ability to learn new systems.
Highly organized and detail oriented


Experience with Quality System Software particularly electronic documentation management preferred

Travel minimal, 0-15% of time domestic travel

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.

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.