Sr. Specialist CSO Documentation and Training

Immediate need for a talented Senior Specialist CSO Documentation and Training. This is a 06+ Months contract opportunity with long-term potential and is located in New Brunswick, NJ (Onsite). Please review the job description below and contact me ASAP if you are interested.
Job ID: 24-00807
Pay Range: $40 - $48/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
Key Responsibilities:

• 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.

Requirements and Technology Experience:

• 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.

Our client is a leading Biopharmaceutical organization and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.
Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.