Global Product Quality Specialist

 
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: 12-month Contract/Full-Time
Job Location: Summit, NJ (Hybrid 50%)
Benefits: Health, Vision, Dental, 401(k)
Compensation: $60 - $70 / hour
 
Job Description:
The Global Product Quality Specialist, will be responsible for managing (and owning as needed) documentation in electronic document management system and change controls associated with key deliverables to clinical and commercial documentation across multiple programs. Functional responsibilities include tracking of multiple work streams and collaborate across multiple functions (i.e. Site QA/QC, manufacturing, validation, IT, manufacturing science and technology, analytical development, etc.) to ensure all technical and compliance requirements are met per clinical and commercial development timelines. Support Change control, Deviation ,CAPA management, APQR(Annual Product Quality Review) and author and/or review GxP documents as required. Provide assistance to other Global Product Quality staff members as needed. Performs other QA duties as assigned.
Basic Qualifications:
• Minimum of 5-7 years of demonstrated success implementing complex business or technology initiatives.
• Minimum of 3 years working under GMP conditions. BA or BS degree.
• Experience managing document authoring reviewing and approving in electronic document system
• Strong written, verbal, and organizational skills, and ability to work in inter-disciplinary and cross-functional teams.
• Experience with eQRMS, infinity, electronic documentation systems (Veeva), and other quality systems is preferred.
• Experience with owning change controls is required.
• Scientific background with basic understanding of typical analytical methods and Quality Control
• Understanding of FDA, EMA, ICH, USP, and EP guidelines and regulations associated with the quality control of biological products.
• Detail oriented with high degree of focus. Able to follow instructions and procedures, both written and verbal.
• Able to understand complex work practices.
• Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects.
• Able to perform with minimal supervision and contribute in a team environment.
• Basic knowledge and ability in using Microsoft Office Package.
 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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