Customer Service Documentation Specialist
Resume:
Kevin Sun
********@*******.***
PERFORMANCE HIGHLIGHTS
Detail-oriented and performance-driven Documentation Specialist with 17+ years of success in document reconciliation, procurement processes, internal and external audits, and month/ year end closing. Excellent problem solving and troubleshooting skills, and the ability to complete an in-depth analysis of records to quickly identify discrepancies and reconcile data. Specialized background with pharma documents and assisting with SOPs and written procedures.
Build strong relations with customers, stakeholders, and auditors to ensure high quality service, negotiate invoicing terms and pass audits with zero citations. Enthusiastic and dedicated Team Player and Team Lead focused on cooperation and willing to step in to ensure compliance and accountability of the records. Trained and coached junior staff on SOPs, Policies and Procedures.
Electronic Document Records Management Trial Master File Documentation Specialist
Good Clinical Practice Veeva Vault Master Control Inventory Control Procurement
Electronic Document Management Systems Office Administration Badging Specialist
TECHNICAL PROFICIENCY
• Key Contributor to successful audits; retrieved, prepared, and verified payment documents and transactions to meet Ernest & Young requirements.
• Improved monitoring and tracking process to ensure payments are processed on time to reduce late charge penalties. Set up and maintain a comprehensive filing system for record
• Selected, hired, and trained new employees.
WORK HISTORY AND ACCOMPLISHMENTS
Clinical Associate II
Gilead contractor (Netpace) Foster City, CA APRIL 2023 to AUGUST 2024
Directs solutions to moderately complex problems
Maintain retention of the Trial Master File and clinical agreements
Uploading documents into Veeva Vault
Review TMF documents and agreements
Develop and maintain department process guidance, training materials, policies and procedures, and other quality documents
Process incoming agreements sent to TMF mailbox
Work with management to develop and maintain quality assurance and control plans
Manage offsite storage of records and ensure proper process is in place for offsite archival of paper agreements
Process inquiries, review of incoming agreement, and filings sent to the DMT mailbox
Inventory Control Services Clerk (Procurement)
Aramark Oakland, CA JULY 2022 to APRIL 2023
Directs solutions to moderately complex problems.
Ensured regular monitoring of records and prompt payment of invoices to vendor
Facilitate the accuracy and on time payments for invoices
Responsible for managing Purchase Orders (POs), reviewing for accuracy completeness and compliance
Estimate budget, processes and development of warehouse budget and planning
Ability to conduct analysis required during a sourcing initiative
Develop and manage strategies for partnering with suppliers
Train staff on procedures and out of stock items
Strong attention to details and processes
Project Manager
Aleut Management Services Oakland, CA JUNE 2013 to DECEMBER 2015
Led building operations and successful audits
Mapping and documenting engineering processes and drawings
Executing change notices for technical drawings
Ensures quality standards are applied to all levels of the work and measured for effectiveness.
Employee Data Management
Directs and approves contract modifications, approves budgets, monitors contractual performance, and costs and takes action to correct discrepant conditions.
Process high volume payment invoices and expense reports
HR Reports and policies
Assist with new hires with all security access card activities
Documentation Specialist
KANG LAI TE Redwood City, CA NOVEMBER 2012 to MAY 2013
Develop strong relationships with vendor
Manage and track status of receipt, filing, renewal, and archival of all clinical TMF/regulatory documents
File and scan documents as needed
Assist with document reconciliation
Attend training as needed for mock audits and inspection readiness.
Perform audit on TMF documentation
Manager, Quality Assurance Records Control
Elan Pharmaceuticals South San Francisco, CA MARCH 2010 to DECEMBER 2011
Heavily contributed to revising SOPs, Procedurals, and training
Manage GXP Documentation and Records Control department
Maintain electronic records in a compliance database
Supervise staff and manage day to day tasks and duties.
Participate in areas that have impact on quality and audits
Assist management with new policies, standards and procedures and classification systems
Lead staff meetings to provide operational updates, plans, and recommendations
Assist in writing new SOPs, Standards, Policies and Guidelines as needed
Maintain and track training records for all employees
Manage archive offsite documentation and records
Supervisor, Clinical Records
Facet Biotech Redwood City, CA FEBRUARY 2007 to JANUARY 2009
Performs quality control activities to ensure complete and accurate case information has been entered into the safety database
Assist in file naming conventions for departmental documents
Coordinate the department special projects
Participates in the creation of policies, procedures, and standard operating procedures.
Lead staff meetings to provide operational updates, plans, and recommendations
Responsible for recording on operational parameters and reporting results to Senior Management
Assist in writing new SOPs, Standards, Policies and Guidelines as needed
Maintain and track training records for all employees
Manage archive offsite documentation and records
Supervisor, Document Management Center
NOVARTIS Oakland, CA MAY 2002 to DECEMBER 2006
Manage day to day operations of the Document Management Center, Medical Records and Data Entry
Developed new document management processes for DMC
TMF bulk scanning and file naming conventions for sorting
Manage departmental electronic document and data conversion into archival system.
Prepared audits as needed for FDA inspection
As Standard Operating Procedures (SOP) administrator, interfaced with executive staff to stay apprised of SOPs and ensure that all Oncology team members complied.
Trained new employees in the documentation process, and coordinated computer, training, and telephone setup
Created filing system and delegated the ongoing maintenance task to qualified team members to support audit activities
Sr. Documentation Coordinator
Bayer Healthcare Oakland, CA MAY 1999 to FEBRUARY 2002
Responsible for maintaining engineering documents both paper and drawings in the EDMS system
Primary contact for all transmittal of documents coming into department
Created training tracking system in alignment with compliance audit readiness
Participate in departmental discussion group and working groups
Ensure current BPRs, cleaning documentation and SOPs for compliance
Set up protocol binders for current and future projects.
Develop plan to house upcoming new project and protocols
Warehouse Clerk/Head Clerk
PAK N’ SAVE FOODS Oakland, CA SEPTEMBER 1993 to FEBRUARY 1998
Responsible cash handling staff monies and assign daily task for employees
Cash handling and training
Conduct light bookkeeping
Stock groceries and product
Build merchandising displays
Manage opening and closing of store
Customer service booth and phones
EDUCATION
PERALTA COLLEGES, Alameda, CA
Courses in Communications, Psychology, and General Education
BUSINESS EDUCATION TECHNOLOGY, Oakland, CA
Diploma Computer Applications for Business
SOFTWARE EXPERTISE
Veeva Vault, Oracle, WIMs, Master Control, Atlas and SAP
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