Address
Form of work CLINICAL SUPPLY, QUALITY MANAGEMENT SYSTEMS (QMS)
RAHWAY, NJ
RAHWAY, NJ
Hybrid Role - Required 3 days onsite (Tuesday / Wednesday with either Monday or Thursday). Fridays work from home.
The pay ranges between $58 - $60 per hour.
Project Description:
- 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 the document management system (QualityDocs).
- 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.
- 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 communication channel between global network site personnel.
- Assist with site metrics collection / reporting and sharing of success stories / achievements as assigned.
- Support 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.
Required 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.
- 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 learning Management Systems.
- Knowledge of process mapping and optimization.
This 12+month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: bridget@alphaconsulting.com
ALPHA'S REQUIREMENT #24-00006
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
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