Quality Specialist Iii (Hybrid)

On-Board Scientific is hiring a Quality Specialist III based out of Rahway, NJ (Hybrid)!
For immediate consideration please send your resume to resumes@onboardusa.com
Subject Line: Position, Title, and State you are Located
About Us:
On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees. We offer benefits as well as 401k.
Position Details:
Position Type: Full Time/ 12 months+ with a possibility of extension
Job Location: Rahway, NJ
Benefits: 401K, Medical, Dental, Vision, and Life Insurance
Compensation: $60 per hour.
Hybrid Role: Required 3 days onsite (Tuesday / Wednesday with either Monday or Thursday). Fridays work from home.
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 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.

NOTE:
The Clinical Supply Quality Management System (QMS) team is part of the larger Global Development Quality (GDQ) organization within our client's Research Laboratory (RL) 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 Global network.
Qualifications:
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).

• 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 learning management systems
• Knowledge of process mapping and optimization.

NOTE: Hybrid Role - Required 3 days onsite (Tuesday / Wednesday with either Monday or Thursday). Fridays work from home.
Apply Today!
www.onboardusa.com
On-Board was founded in 1976 by Robert L. Wilson to provide Engineering and Design services to the chemical manufacturing industry. Today, On-Board is a thriving privately held family of companies with services including Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America.
The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC. On-Board's Mission is to provide "Flexible Service by applying the talents of our people, work processes and technology to meet our clients' expectations in a Safe, Responsible and Dependable manner."
On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability, or genetics.
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