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Specialist, Document Management
- West Pharmaceutical Services (Exton, PA)
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Specialist, Document Management
Requisition ID:
70948
Date:
Aug 1, 2025
Location:
Exton, Pennsylvania, US
Department:
Quality
Description:
This is a hybrid role (3 days onsite) in Exton, PA. Candidates applying must be residing within a commutable 50 mile radius to the job location.
Who We Are:
At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?
There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.
We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.
Job Summary
This role is accountable for providing document control and learning management services to support a multi-functional team environment. This role will support document control and database administration activities within the Quality team and will identify areas of improvement. This role will handle projects and tasks consistent with internal procedures and acceptance criteria, while meeting company and regulatory requirements.
Essential Duties and Responsibilities
+ Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations and standards
+ Manage and maintain traceable, accountable, password protected, documentation system in compliance with Corporate and site Quality requirements
+ Serve as a MasterControl sub-administrator for user management, reporting, troubleshooting, and system configuration.
+ Serving as an LMS administrator for local Quality functions, maintaining training matrices and curricula and managing quizzes.
+ Ensure compliance with periodic review requirements for all procedures.
+ Ensure consistency of document structure & compliance to company procedures, ISO standards, GDPs & cGMPs.
+ Work cross-functionally with individuals and projects teams to ensure successful documentation release.
+ Provide quality document control oversight on documentation and reports.
+ Review documents for clarity, grammar.
Education
+ Associate's Degree in technical or business-related field required
Work Experience
+ Minimum 3 years of experience in regulated Quality Assurance / Quality Control required and
+ Relevant work history and/or experience may be considered in lieu of degree required and
+ Experience with managing Document Control activities within a regulated industry required and
+ Experience with quality systems such as ISO 9001, ISO 13485, 21 CFR 820 preferred and
+ Experience with MasterControl (preferred) or electronic document management systems
Preferred Knowledge, Skills and Abilities
+ Ability to work independently, multi-task and thrive in fast-paced environment
+ Excellent written and verbal communication skills
+ Must have effective problem solving and interpersonal skills
+ Proficient in Windows OS, Microsoft Office Suite including Word, Excel, and Power Point
+ Ability to accurately collect and organize data
+ Able to be aware of all relevant SOPs as per Company policy and Quality Manual
+ Able to comply with the company’s safety policy at all times
LI-NJ1
LI-hybrid
Travel Requirements
5%: Up to 13 business days per year
Physical Requirements
Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and/or drug screening.
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Recent Jobs
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Specialist, Document Management
- West Pharmaceutical Services (Exton, PA)