Global Product Development And Supply - Sr. Specialist Cso Documentation And Training

Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Senior Specialist CSO Documentation and Trainingfor our client in New Brunswick, NJ.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
Position Overview:

• 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:

• 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

Required Skills:

• 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

Qualifications:

• Bachelor's Degree Required; Preferred if candidate has over 8 yrs experience without the degree

If hired, you will enjoy the following Eclaro Benefits:

• 401k Retirement Savings Plan administered by Merrill Lynch
• Commuter Check Pretax Commuter Benefits
• Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro

If interested, you may contact:
Chris Imbien
Chris.Imbien@eclaro.com
(843) 872-9257
https://www.linkedin.com/in/chris-imbien-08587820b/
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.