Resourceful Specialist offering expertise in problem-solving, data analysis and customer service. Adept at quickly learning new technologies and processes for driving success. Proven track record of successfully managing multiple projects and developing innovative solutions.
SAP Functions
*Processing of work orders to keep SAP equipment and functional location masters current *Perform changes to cycle driven maintenance plans and SOP documents
*Participate in applicable SAP enhancement projects and Bill of Material (BOM) projects
*Perform in the field verification and equipment labeling
*Responsible for the Notification and Corrective Work Order Backlog
*Review/screen each work order to see that the scope of work is clearly described, assess the priority and requested completion date for realistic goals and discusses the details of requested work with originating department as necessary
*Evaluate current Good Manufacturing Practices (cGMP) impact of systems when planning and scheduling work, and openly communicate impact with department management and ensures consensus for repair
*Seek ways to increase operational efficiency and the conservation of company resources Planning/Scheduling
*Serve as the principal contact and liaison between the maintenance department and the customer departments served by maintenance and ensures that the applicable operations areas receive prompt, efficient and quality service from the maintenance department
*Perform in the field assessments of work notifications to accurately assess and plan the work
*Plan and schedules preventive maintenance work in coordination with operations and E&F personnel
*Obtain supplies, parts and materials required to perform the work requested per SAP purchase requisitions
*Ensure job kits are created and made available as scheduled in SAP, and ensures backlog is maintained within recommended quantity
*Ensure that safety needs are given a top priority in work planning
*Develop a file of standard work orders (plans) for regularly recurring repair jobs, based on historical experience, to simplify the planning process
*Support Departmental Reporting and Tracking Initiatives
Veeva Vault
*Update and Review SOPs
*Initiate and Complete Quality Notifications: Deviations, Change Controls, CAPAs, and Change Actions
Baltimore site Engineering and Facilities (E&F) Departments and Environmental Health and Safety (EH&S) Department
*Provides extensive administrative/business support
*Acts as coordinator of departmental projects
*Coordinate Engineering and Facilities work order scheduling (SAP) *Manage procurement for E&F and EH&S Department
*Track and Report on Engineering and Facilities Budgets
*Assist in budget preparation and monthly expense reporting to Finance *Maintain files for departmental contracts, purchase orders,invoices, etc. *Manage E&F and EH&S inventories
*Assist in creating internal and external reports for the department *Assist in reporting for Environmental Permitting
*Assist in safety record management
*Manage department calendars
*Manage department training records and status
*Manage departmental files (current and historical) including equipment files -Operation/Maintenance manuals
*Process expense reports, timecards, and requests for time-off for E&F *Manage recurring meetings
*Maintain agendas, supporting documents, handle meeting logistics (food service, take/distribute minutes)
*Make travel arrangements
*Coordinate and schedule meetings and conference calls
*Space Planning, Lead the organization and coordination related to site space and seating planning
SAP Functions
*Lead the Setup of New Equipment and Systems and their associated plans in SAP
*Lead the Setup of BOMs and the Administration of the spare parts warehouse inventory
*Execute the Generation of Work Orders
*Serve as the EDOCS Departmental super-user
*Support the setup of new procedures as required.
*Manage the biennial review process for the department
*Procurement Support
*Coordinate New Vendor Setups
*Lead the generation, as needed, for purchase requisitions related to General Administration, CAPEX, Engineering and EHS.
*Support Various Site / Departmental Reporting and Tracking Initiatives *Departmental Metrics
*Spending Tracking (Opex and Capex)
*Compliance Tracking
*Staffing and Resource Analysis
*Serve as the Administrator for the Engineering Department Share Point Site
*Coordinate and oversee departmental training programs
Document Control System
* Implement and maintain
* Assign Controlled Document numbers and maintain associated logs
* Oversee the approval and issuance of Controlled Documents
* Control access to and maintain the electronic manual files of original and controlled copies of documents
* Coordinate routine review of Controlled Documents
Records Management System
* Implement and maintain
* Coordinate/manage the submission,storage,retrieval and retention of records
* Control access to original electronic and manual records
* Perform periodic review of document retention periods and coordinate transfer of records to off-site storage
Change Control System
* Implement and maintain
* Assign change control numbers and maintain associated logs
*Control access to and maintain all change control files and associated documents
Training System
* Implement and maintain files for employees, contractors, consultants, and vendors,as needed
* Issue training forms,SOPs and training packets for new employees and contractors, as needed
* Schedule site training and prepare binders for site training, as needed
* Conduct training sessions
COMMUNICATION: REPORTS/PRESENTATIONS/TECHNOLOGY
* Prepare complex reports for management, ensuring full compliance and meeting deadlines * Design and deliver computer-based training based on monthly training
* Rapidly learn and master various computer programs
CUSTOMER SERVICE/PROBLEM SOLVING
* Develop and implement procedures, processes, and tools to support the facility (cGMP Compliant)
CURRENT MASTERY/ORGANIZATION
* Manage and Maintain Training Databases by managing the daily operations of the Training Records Center - over 500 confidential quality assurance employee and contractor training files (i.e. Qualification Cards & Operator Certifications, Modular Program Qualifications and Certifications) and over 300 course training files, Input and verify accuracy of training information into appropriate system. Manages system upgrades when applicable
* Maintain Employee Training Qualification Matrices for Each Department, Maintain Employee Module Program Requirements, *Maintain the employee training website (Student Center), which includes the following: Training Profile, Training Calendar, Personnel Transcript, Training Plan, Class Schedules, Course Catalog, Bulletins, Online Reports, Not Met Training Reports, and Assigned Curriculums
* Develop and Manage electronic performance systems, such as the TrainingInformation Management Systems (SumTotal/Pathlore), CBTs, Web- based training.
* Publish New or Updated Online Course Content (Coastal/ CompuPharma)
* Administer and manage the Training Matrix Compliance Program (over 800 active SOPs vital to plant operation), Email electronic reads for new or revised SOP's/ESH Policies to employees
COMMUNICATION: REPORTS/PRESENTATIONS/TECHNOLOGY
* Prepare complex reports for management, ensuring full compliance and meeting deadlines
* Design and deliver computer-based training based on monthly training
* Rapidly learn and master various computer programs
CUSTOMER SERVICE/PROBLEM SOLVING
* Develop and implement procedures, processes, and tools to support the facility (cGMP Compliant)
CURRENT MASTERY/ORGANIZATION
* Manage and Maintain Training Databases by managing the daily operations of the Training Records Center - over 500 confidential quality assurance employee and contractor training files (i.e. Qualification Cards & Operator Certifications, Modular Program Qualifications and Certifications) and over 300 course training files, Input and verify accuracy of training information into appropriate system.
* Manages system upgrades when applicable
* Maintain Employee Training Qualification Matrices for Each Department
* Maintain Employee Module Program Requirements
* Maintain the employee training website (Student Center), which includes the following: Training Profile, Training Calendar, Personnel Transcript, Training Plan, Class Schedules, Course Catalog, Bulletins, Online Reports, Not Met Training Reports, and Assigned Curriculums
* Develop and Manage electronic performance systems, such as the Training Information Management Systems (SumTotal/Pathlore), CBTs, Web- based training.
* Publish New or Updated Online Course Content (Coastal/ CompuPharma)
* Administer and manage the Training Matrix Compliance Program (over 800 active SOPs vital to plant operation), Email electronic reads for new or revised SOP's/ESH Policies to employees
COMMUNICATION: REPORTS/PRESENTATIONS/TECHNOLOGY
* Prepare complex reports for management, ensuring full compliance and meeting deadlines
* Designand deliver computer-based training based on monthly training
* Rapidly learn and master various computer programs
CUSTOMER SERVICE/PROBLEM SOLVING
* Develop and implement procedures, processes, and tools to support the facility (cGMP Compliant)
CURRENT MASTERY/ORGANIZATION
* Manage and Maintain Training Databases by managing the daily operations of the Training Records Center - over 500 confidential quality assurance employee and contractor training files (i.e. Qualification Cards & Operator Certifications, Modular Program Qualifications and Certifications) and over 300 course training files, Input and verify accuracy of training information into appropriate system.
* Manages system upgrades when applicable
* Maintain Employee Training Qualification Matrices for Each Department
* Maintain Employee Module Program Requirements
* Maintain the employee training website (Student Center), which includes the following: Training Profile, Training Calendar, Personnel Transcript, Training Plan, Class Schedules, Course Catalog, Bulletins, Online Reports, Not Met Training Reports, and Assigned Curriculums
* Develop and Manage electronic performance systems, such as the Training Information Management Systems (SumTotal/Pathlore), CBTs, Web- based training. Publish New or Updated Online Course Content (Coastal/ CompuPharma)
* Administer and manage the Training Matrix Compliance Program (over 800 active SOPs vital to plant operation), Email electronic reads for new or revised SOP's/ESH Policies to employees