Sr. Specialist CSO Documentation and Training
Apply NowCompany: Omni Inclusive
Location: New Brunswick, NJ 08901
Description:
S r. Specialist, CSO Documentation and Training
Department/Division: CSO-NBR Compliance & Business Operations
This role is 100% Onsite in New Brunswick, NJ
Work Schedule: Mon - Fri, Business Hours
This role, is a key role in CSO organization to ensure day to day compliance within organization as it pertains to GxP documentation and training. This role will work with multiple departments across Product Development to communicate effectively for all Training and Doc related issues. The position manages the controlled documentation (Standard Operating Procedures, Forms, other controlled documents, etc.) for CSO NBR Manufacturing along with Training.
Responsibilities and Tasks:
Develop training curriculum, evaluate/monitor training materials, record training activities and program
effectiveness
Conducts integrated training needs assessments, organize, and develop, training procedure guides and/or course
materials and provide trainings onsite or remote
Work with CSO departments to ensure training curriculum is appropriate and focused based on job functions
As a Content manager of various PD Electronic Document Management systems (ie PDHQ, Corporate Docs,
Docman), create, review, control and maintain CSO controlled documents related to clinical manufacturing
activities.
Provide support for periodic review workflows, CAPAs, maintenance of CSO JDs, CVs, etc.
Process/Manage GMP documents using electronic systems according to Global/Site procedures
Manage creation, review, and process of CV, JDs, and Signature Logs, as required.
Generate Metrics for Training and Doc team
Perform Quality investigations including accurate root cause analysis and ensure timely completion of
investigations.
Support continuous improvement efforts
Ensure Training and Documentation data are properly captured, stored, archived, available and maintained in an
audit ready state.
Assist with the training programs as needed such as 'train the trainer' programs.
Identifies and escalates technical and/or business issues promptly; must be able to have the ability to solve routine
issues independently.
Completes routine Documentation and Training tasks with little or no supervision
*Disclaimer: The responsibilities listed above are only a summary and other responsibilities may be added upon business needs.
Experience Required:
Must Have Experience with Learning Management Systems (i.e SuccessFactors, Compliance wire, etc) and QMS
Documentation Systems (i.e., CDMS, EDMS, Veeva etc)
Advanced Knowledge of Microsoft Office (Excel, Word, SharePoint etc)
Experience in Deviation writing, Change Controls, etc
Excellent attention to details with ability to work accurately and independently in a busy demanding environment.
Strong collaboration and communication skills
Ability to successfully work within strict timelines showcasing excellent organizational and time management skills.
Ability to negotiate and act as a mediator between functional areas while meeting timelines and pay attention to
details.
Person must have good work ethic, be able to work independently as well as with others on the team
Education:
Bachelor's Degree Required; Preferred if candidate has over 8 yrs experience without the degree
Physical Requirements:
Must be able to lift 1 to 5 pounds, sitting, standing, walking area as required
Department/Division: CSO-NBR Compliance & Business Operations
This role is 100% Onsite in New Brunswick, NJ
Work Schedule: Mon - Fri, Business Hours
This role, is a key role in CSO organization to ensure day to day compliance within organization as it pertains to GxP documentation and training. This role will work with multiple departments across Product Development to communicate effectively for all Training and Doc related issues. The position manages the controlled documentation (Standard Operating Procedures, Forms, other controlled documents, etc.) for CSO NBR Manufacturing along with Training.
Responsibilities and Tasks:
Develop training curriculum, evaluate/monitor training materials, record training activities and program
effectiveness
Conducts integrated training needs assessments, organize, and develop, training procedure guides and/or course
materials and provide trainings onsite or remote
Work with CSO departments to ensure training curriculum is appropriate and focused based on job functions
As a Content manager of various PD Electronic Document Management systems (ie PDHQ, Corporate Docs,
Docman), create, review, control and maintain CSO controlled documents related to clinical manufacturing
activities.
Provide support for periodic review workflows, CAPAs, maintenance of CSO JDs, CVs, etc.
Process/Manage GMP documents using electronic systems according to Global/Site procedures
Manage creation, review, and process of CV, JDs, and Signature Logs, as required.
Generate Metrics for Training and Doc team
Perform Quality investigations including accurate root cause analysis and ensure timely completion of
investigations.
Support continuous improvement efforts
Ensure Training and Documentation data are properly captured, stored, archived, available and maintained in an
audit ready state.
Assist with the training programs as needed such as 'train the trainer' programs.
Identifies and escalates technical and/or business issues promptly; must be able to have the ability to solve routine
issues independently.
Completes routine Documentation and Training tasks with little or no supervision
*Disclaimer: The responsibilities listed above are only a summary and other responsibilities may be added upon business needs.
Experience Required:
Must Have Experience with Learning Management Systems (i.e SuccessFactors, Compliance wire, etc) and QMS
Documentation Systems (i.e., CDMS, EDMS, Veeva etc)
Advanced Knowledge of Microsoft Office (Excel, Word, SharePoint etc)
Experience in Deviation writing, Change Controls, etc
Excellent attention to details with ability to work accurately and independently in a busy demanding environment.
Strong collaboration and communication skills
Ability to successfully work within strict timelines showcasing excellent organizational and time management skills.
Ability to negotiate and act as a mediator between functional areas while meeting timelines and pay attention to
details.
Person must have good work ethic, be able to work independently as well as with others on the team
Education:
Bachelor's Degree Required; Preferred if candidate has over 8 yrs experience without the degree
Physical Requirements:
Must be able to lift 1 to 5 pounds, sitting, standing, walking area as required