Sr. Specialist CSO Documentation and Training

Primary Talent Partners has a 6-month contract opening for a Sr. Specialist CSO Documentation and Training, with a global pharmaceutical client in New Brunswick, NJ.
Job Title: Sr. Specialist, CSO Documentation and Training
Pay: $45.00 - $48.50 / hour
Location: New Brunswick, NJ - 100% on-site 5 days a week
Work Schedule: Mon - Fri, Business Hours
Term: 6-month contract - Possible extension
Note: No C2C or sponsorship is provided
Job Description:
This role is a key role in the CSO organization to ensure day-to-day compliance within the 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, organizes, and develops, training procedure guides and/or course materials, and provides training onsite or remote
• Work with CSO departments to ensure the 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 the 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 detail with the 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 paying attention to details.
• The person must have a 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

Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.
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