Documentation Systems Manager

Job Description

Title: Documentation Systems Manager
Duration: 6 Months
Location: Foster City, CA

The Documentation Systems Manager, Corporate Engineering provides technical leadership and accountability for all documentation systems maintenance for the engineering and research and development (R&D) laboratories, clinical manufacturing related facilities, warehouses, and office buildings at Client's Corporate Headquarters in Foster City, CA. Position reports to Associate Director of Technical Engineering.

Essential Duties and Job Functions:
• The Document Manager, will work effectively on multi-discipline engineering capital project teams, as well as other non-project related cross-functional teams.
• Document Manager will store, manage and track company documents. They scan, image, organize and maintain documents, adhering to the company's document lifecycle procedures, and they archive inactive records in accordance with the records retention schedule.
• Document Manager will be responsible for training employees on records management procedures and policies, which include documentation, retention, retrieval, destruction and disaster recovery.
• Interface with the Project Teams to develop documentation plan in the preliminary phases of the project.
• Responsible for importing data, drawings, and other relevant documents into the new EDMS Project, and maintain document integrity ownership of the multisite EDMS.
• Participate in developing documentation plans for facility systems, process systems and equipment. Participate in identifying critical parameters/instrumentation, and critical function of the facility system and process/equipment in order to properly categorize documents within the EDMS. Review and assess impact of document changes to the qualification status of process system/equipment and facility systems, and feed information into proper change control procedures.
• Coordinate construction walk-through, develop and maintain deficiency list (punch list and exceptions list) with Construction Managers and CX/CQ team as needed.
• Audit project documentation for turnover to the customer to ensure compliance.
• Develop and Implement all required training for global EDMS system.
• Throughout project lifecycle, collect and properly land start-up documentation for turnover to Production and Facility Maintenance, and other customer groups.
• Ensure project safety. Ensure that all work is performed in full compliance with SHE, Good Manufacturing Practices, Standard Operating Procedures, and Good Engineering Practices.
• Directly supports capital projects by accepting and overseeing storage of all documentation with the documentation team for all equipment.
• May interface with regulatory agencies as required.
• Develops and improves concepts, techniques, and standards for future documentation GEPs.
• Take ownership of Turn Over Packages and their incorporation for all projects.
• Ensures project work complies with established practices, policies and processes.
• Provides leadership to the team and functional areas to anticipate and identify complex project documentation issues which pose a challenge to achieving strategic goals; proposes and implements plans to resolve such issues and execute corrective actions.
• Must have a proven track record in managing people and providing the resources to make others productive and successful in their roles and responsibilities.
• Develops, implements, and maintains documentation programs and processes to ensure high quality of operations, and compliance with UBC, UFC, NEC codes, current Good Manufacturing Practices (GMPs), Good Engineering Practices (GEPs) and Good Laboratory Practices (GLPs).

This position is expected to be an effective communicator of ideas, engineering goals and results. With minimal supervision, is expected to make presentations and updates to senior management and in broader forums both internal and external to Client.

Qualifications

Knowledge, Experience and Skills:
• 10+ years of relevant experience in document control in a GMP environment.
• Experience should include 5 years of participation in cross-functional technical project execution in various stages of construction.
• Working knowledge of GMP and GEP documentation practices.
• Strong writing and verbal communication skills.
• Demonstrated oral/presentation and written communication skills across levels and departments.
• Experience with Blue Cielo – Meridian system is preferred.

Additional Information

Kind Regards,

Sabanaaz Shaikh

Clinical Recruiter

Integrated Resources, Inc.

IT Life Sciences Allied Healthcare CRO

Gold Seal JCAHO Certified ™ for Health Care Staffing

“INC 5000’s FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)