• Job Type:Contract

Posted 27 days ago

Job 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. Functional responsibilities include coordinating the sites 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

• industry and Management of Document Center and physical records.

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.

Contact:

Full Name: Akash Mehra

Email ID: akashm@askconsulting.com

Phone: 908-224-9613