Job Title: Document Control

Tax Work Location: WRN, NJ

Duration : 12 Months

Document Control Specialist

100% Onsite

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. Functional responsibilities include coordinating the site’s document control

process, GMP training, and participating in global quality systems projects.

REQUIRED COMPETENCIES:

Knowledge, Skills, and Abilities-

• 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.

Duties and Responsibilities: -

• 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.

Education and Experience:

• B.S. degree preferred, minimum of five years of experience in the pharmaceutical or related industry and Management of Document Center and physical records.

Job Type: Full-time

Pay: $36.00 - $36.62 per hour

Benefits:

• 401(k)
• Dental insurance
• Vision insurance

Schedule:

• 8 hour shift
• Day shift

Ability to commute/relocate:

• Township of Warren, NJ 07059: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Microsoft Office: 1 year (Preferred)

Work Location: One location

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