Document Controls Manager (Facilities/Engineering/CAD/BIM)

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Sep 14, 2020
Ref
R0014784
Required Education
Bachelors Degree
Position Type
Full time
Kite is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job

Job Description

We are seeking a qualified professional to join our team as a Document Controls Manager. The Document Controls Manager will be responsible for managing company facility documents content capture, workflow and document repositories across all Kite facilities, utilizing COLD/ERM output systems, and information retrieval systems. The Document Controls Manager will also oversee the processes used to track, store and control facilities documents while also ensuring their accuracy, quality and integrity. The manager is required to adhere to record retention policies, safeguard information and facilitate the retrieval data more effectively. Experience in Meridian and EIDA document management systems are a plus

The Document Controls Manager will be responsible for developing, with the facilities engineering management team, documentation guidelines, systems and processes required to address records retention requirements, change management, documentation for physical engineering/construction activities. The document controls manager will be responsible for ensuring all Kite facilities are in compliance of the company document controls requirements.

Skills and Background Preferred:

• Knowledge of tracking changes and developing document revisions.

• Have solid knowledge of FDA requirements and processes.

• AutoCAD proficiency / Working understanding of Revit

• Ability to develop Standard Operating Procedures (SOP) trainings and Forms

• Have good communication skills and able to work with multiple departments and trades.

• Experience in biotechnology and pharmaceutical industries. Experience in other related industries are acceptable

• Experience in large scale documentation management systems

• Self-starter attitude with proactive, results-oriented focus; and willing and capable to assume additional responsibilities.

• Prior demonstrated experience managing a group of five or more Document Control Technicians is desired.

• Proven accuracy, reliability and completeness in job accomplishment.

• Demonstrated success on the job, as evidenced by satis¬¨factory performance, acceptance of responsibility and growth in previous positions.

• Effective oral and written communication skills.

• Ability to interface with a variety of people with different technical levels and educational backgrounds; must be detail-oriented and highly organized; and must be able to produce accurate and timely results while maintaining a professional attitude.

• Ability to instill a "can-do" spirit within the Document Control Technician staff: inspiring them to produce consistently accurate results at a fast pace.

Technical Ability Requirements:

The Document Controls Manager must have experience and knowledge in engineering and facilities document management. In addition, the individual must have strong, records management experience and FDA and GMP regulated facilities. The individual must have a good understanding of all types of facilities engineering and construction documentation as well as CQV reference documentation needed to support facilities maintenance and management activities.

Functions (Duty / Accountability)

• Establishing a procedural framework for identifying, collecting, distributing and filing the controlled documents for the company. This involves writing and maintaining document control procedures and participating in the development and roll-out of document control tools, such as scanning hardware, computer software, etc.

• Ensure the information and management control system is implemented in compliance with Kite standards; and is updated to reflect revisions to those standards. Maintain awareness of new/or Kite process initiatives that may impact the control or distribution of information.

• Ensure the Project Team members are provided with adequate training and support to enable them to successfully use the procedure and systems in use by the Document Management Program. Proactively conduct "spot audits" and "over-the-shoulder-reviews" of Project Teams to facilitate their understanding of and enhance their compliance to Document Controls procedures.

• Contracting and managing a group of Document Control Technicians.

• Provide an interface to IT Support for Document Control issues, which include process enhancements to existing software, developing recommendations for new hardware and/or software that may benefit the Document Control environment. In general, identify trends and recommend "best practices."

• Maintain a watchful and alert attitude toward Document Control, including inserting the Document Control Technicians into Project Team meetings, developing routine reports and metrics to gauge a Project Team's success.

Educational and Professional Qualifications:

• A four-year degree is preferred.

• 10+ years of document control experience, with at least five-years supporting engineering and construction projects, preferably in the private-sector.

• Experience with Microsoft Office Suite of software is required.

• Experience with AutoCAD is required. Revit experience is desired.

• Experience with Adobe Acrobat is required.

• Experience with large-scale Document Control Software is required, Prolog and/or Documentum highly desirable.

• Demonstrated experience with routine Document Control hardware and software, such as scanners, optical character recognition.

#IND123

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

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For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.