Quality Systems Specialist

Title: Quality Management Specialist

Location: Rahway, NJ 07065 OR West Point, PA 19486 (The candidate has a provision to choose)

Duration: 12 Months

Hybrid and the candidate needs to be onside as per the manager’s need.

Qualifications

The primary role will be to support the Quality Management Systems teams with various tasks including, but not limited to documentation and project support activities. The role requires interaction with learning management systems; MyLearning and Quality Docs.

Required Education & Skills:

·        Bachelor’s Degree in an appropriate scientific or business field of study

·        Minimum of five (5) years experience in the Pharmaceutical or equivalent industry

·        Strong technical knowledge, skills, and experience in project and documentation management

Preferred Education & Skills:

·        Excellent verbal and written communication skills as well as presentation skills

·        Strongly developed cross-functional teamwork and collaboration skills

·        Experience in Microsoft tools such as Outlook, Word, Excel, PowerPoint, SharePoint, Teams and Project is strongly recommended

·        Experience with document editing in MS Word (e.g. formatting, forms, styles, templates, etc.)

·        Experience directly related to the development of Quality Standards and core requirements for Market Supply and/or Clinical Supply

·        Experience directly related to Quality Assurance, Quality Control, GMP regulations or pharmaceutical regulations

·        Knowledge of processing mapping and optimization.

Responsibilities:

Key collaborator working closely with site personnel and Clinical Supply QMS Redesign Team to ensure successful implementation of new QMS by assisting with project-specific tasks, including but not limited to, project support, document management, documentation review, technical editing, meeting coordination and facilitation, training, onboarding, and other administrative tasks.

Specific tasks may include:

·        Perform documentation review and technical editing to ensure consistency (e.g. language, formatting, etc.) within the Redesign Team and across the Clinical Supply network

·        Serve as a communication channel between global network site personnel

·        Assist with site metrics collection/reporting and sharing of success stories/achievements

·        Support the development of the learning strategy for new and revised QMS topics, including access to LMS content and generation of reports, creation of training materials, and communication of training requirements

·        Support project management activities, optimization of communication strategy, and change management strategy

·        Management of document lifecycle (new or existing documents) and review/approval workflows

·        Maintain electronic repository/communication mechanism (e.g. QMS SharePoint Site, Microsoft Teams)

·        Serve as a change agent helping the Clinical Supply QMS Redesign Team drive culture change.

NOTE: The Clinical Supply Quality Management System (QMS) team is part of the larger Global Development Quality (GDQ) organization within the Research Laboratory Quality Assurance and is responsible for the design, implementation, and long-term maintenance of a new QMS, including Quality Standards and Global Procedures, for all sites performing Clinical Supply functions within the client’s Global network.