Sr. Specialist CSO Documentation and Training

Our client, a Top Pharmaceutical company needs a “Sr. Specialist CSO Documentation and Training” in New Brunswick, NJ ASAP.

Job Description:

Job Title: Sr. Specialist CSO Documentation and Training

Location: New Brunswick, NJ

Duration: 6 Months

Pay Rate: $46- $48/hr on W2

Job Description:

• 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

Sr. 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