Demo

Quality Management Specialist - QMS 25-18732

NavitsPartners
North Wales, PA Full Time
POSTED ON 1/16/2025
AVAILABLE BEFORE 4/12/2025

Job Description

Job Description

Job Title : Quality Management Specialist

Location : West Point, PA 19486

Duration : 12 Months

Work Arrangement : Hybrid (Onsite presence required as per manager’s needs)

Job Overview :

We are seeking a skilled Quality Management Specialist to support Quality Management Systems (QMS) teams in documentation, project management, and system implementation tasks. The role involves collaboration with site personnel and the Clinical Supply QMS Redesign Team to ensure the successful integration of new QMS processes.

Responsibilities :

  • Collaborate with site personnel and QMS Redesign Team to support project-specific activities.
  • Perform documentation review and technical editing to ensure consistency in language and formatting across the Clinical Supply network.
  • Serve as a communication link between global site personnel.
  • Assist with metrics collection, reporting, and showcasing success stories / achievements.
  • Develop and implement learning strategies for QMS, including LMS content access, training material creation, and communication of requirements.
  • Manage document lifecycle, review / approval workflows, and maintain electronic repositories (e.g., SharePoint, Microsoft Teams).
  • Support project management activities, including change management and optimization of communication strategies.
  • Facilitate meetings, coordinate training sessions, and assist with onboarding activities.
  • Act as a change agent, driving culture change within the Clinical Supply QMS Redesign Team.

Qualifications :

Required Education & Skills :

  • Bachelor’s Degree in a scientific or business field.
  • Minimum of 5 years of experience in the pharmaceutical or equivalent industry.
  • Strong technical skills in project management and documentation.
  • Preferred Education & Skills :

  • Proficiency in Microsoft tools, including Outlook, Word, Excel, PowerPoint, SharePoint, Teams, and Project.
  • Experience with document editing in MS Word (formatting, templates, forms, etc.).
  • Strong verbal and written communication and presentation skills.
  • Collaboration and teamwork capabilities across cross-functional teams.
  • Experience in Quality Standards and core requirements for Market or Clinical Supply.
  • Familiarity with GMP regulations, Quality Assurance, and Quality Control.
  • Knowledge of process mapping and optimization techniques.
  • Additional Notes :

  • This role supports the Clinical Supply Quality Management System (QMS) Team, which is part of a larger organization responsible for the design, implementation, and long-term maintenance of a new QMS.
  • The position will focus on developing and maintaining Quality Standards and Global Procedures for Clinical Supply functions within a global network.
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