Document Control Specialist
Hays

The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.

A Pharmaceutical Company is seeking a Document Control Specialist in Princeton, NJ.

Role Description

The Specialist is responsible for support from a Subject Matter Expert (SME) standpoint in accordance with Cell Therapy Development Operations (CTDO) policies, standards, procedures, and Global cGMP.

• Serve as the Administrator of the document control database system.
• Review and approve site procedures and documents within the document control system.
• Manage the periodic review program for site documents.
• Support assignment of training curriculums for site personnel.
• Provide back up support to the Training Specialist for Learning Management System functions.
• Drive Quality System harmonization with other sites and teams within CTDO.
• Management of Document Center and physical records.
• Issue and manage logbooks and laboratory forms.
• Provide end user system access training.
• Provides customer support for system and processes.

Skills & Requirements

• Must have experience with cGMP Manufacturing, Quality, and Compliance.
• Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
• Must be action-oriented, customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
• Must possess an independent mindset.
• Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
• Work is self-directed.
• Confident in making decisions for minor issues.
• Routinely recognizes Quality issues and solves problems.
• Proposes solutions for complex issues and works with management to resolve.
• Follows established procedures and performs work as assigned.
• Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution
• Is recognized Subject Matter Expert within the group.
• Provides guidance to other employees in interpretation of complex data.
• Capable of providing input within the department and cross functional teams.
• Builds relationships internally within and with cross functional teams.
• Contributes to goals within the work group.
• Able to recognize conflict and notify management with proposed recommendations for resolution.
• Able to prepare written communications and communicate problems to management with clarity and accuracy.
• Able to effectively multi-task and execute project management skills. Knowledge of US and global cGMP requirements.
• Excellent verbal and written communication skills.
• B.S. degree preferred, minimum of five years of experience in the pharmaceutical or related industry and Management of Document Center and physical records.

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.

Additionally, this position is a contract role where Hays offers you the opportunity to enroll in full medical, dental or vision benefits.

• Medical
• Dental
• Vision
• 401K
• Life Insurance ($20,000 benefit)

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Hays is an Equal Opportunity Employer including disability/veteran.

In accordance with applicable federal and state law protecting qualified individuals with known disabilities, Hays U.S. Corporation will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570

Drug testing may be required; please contact a recruiter for more information.
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