Accenture Scientific Informatics Services (ASIS) business unit. Multiple roles working on Delivery and Operations, Project Management, and GxP Compliance. With a focus on client SLC deliverables for laboratory implementation in Pharma, Life Science R&D, and Chemicals. • Led a global client initiative to upgrade lab PC hardware and software across nine laboratories, coordinating the procurement of nearly 700 instruments and managing relationships with over 50 vendors and 100 distinct software platforms.• Managed the global implementation of NuGenesis SDMS v9, including system configuration, development, execution, and review of IQ, OQ, and UAT test scripts. Authored detailed work instructions critical to the computer system validation documentation process. • Served in various client-facing roles, leveraging expertise in life sciences, software implementation, and validation to successfully deliver projects within strict deadlines.

Technical leader for Global Information Systems team working directly with Laboratory Management in QC and R&D providing oversight and expertise during projects, enhancements and upgrades in the areas of infrastructure, solution design, security and access controls, file management, backup and recovery, and testing.• Technical representative for the Global Information Systems (GIS) team to work with QC and AR&D on new system instrumentation. Validating software using VP, URS, IOQ, PQ and VR for system lifecycle qualification.• Ensure Data Integrity on Laboratory Systems by conducting quarterly maintenance checks that include audit trail verification checks, user list verification, computer system health status and software patches or upgrades.

Provided direct technical oversight and administration for the Quality Control (QC) Metrology Group supporting all laboratory data systems ensuring technology solutions were implemented, supported and maintained in a validated state in accordance with internal governance and regulatory requirements including Part 11 and Data integrity guidance.

Responsible for technical oversight and support for the quality, manufacturing, packaging, and laboratory areas ensuring that systems were implemented and remained in a validated state to support business operations.

• Provide services for generation and control of master and executed documentation for Quality and Operations Staff.• Prepare and maintain documentation that include Validation Studies, Certificates of Analysis, Protocols, Change Control Request, Deviation Reports, Standard Operating Procedures (SOP), Specifications, Methods for Testing, Log Books, Laboratory Notebooks, and Worksheets.• Process and retrieve technical documentation and process master documentation in accordance with SOP’s.

• Worked with the new product developers to coordinate the process of labels from formulation to advertising, including contacting vendors for Raw Material information and gathering all required label documentation for Nutrition/Regulatory Department.• Entered Raw Materials to Genesis to create a Supplement or Nutritional Facts Box along with Ingredient Listing. • Created Finish Product Specifications (FPS) for contract-manufactured goods using the EDMS system and coordinate track and maintain documentation for contract manufacturer approval.

• Coordinated and handled Document Control operations per SOP’s and controlled internal and contract Manufacturing Departments (raw materials, bulk specs, and master batch records) for short term and archival use.• Prepared, processed, and maintained the raw material specifications in the EDMS computer system while assisting and training scientist in the company procedure.• Maintained the Raw Material Scan Database for Scientist and Raw Material Spec approvers to view the Vendor Spec Sheets, Certificates of Analysis, and other documents related to the material.

• Input and maintained the Bill of Material (BOM) and Engineering Change Order (ECO) data for all product Channels; Maintained over 98,700 part numbers and input over 37,000 items to JD Edwards (JDE).• Integrated Bill of Material and item master data into JDE during a period of multiple acquisitions as the company tripled in size. • Maintained new product launches, shipping and delivery schedules by attending weekly meetings and making the updated changes to the company’s New Product Tracking Database.

• Provided quality customer service by averaging 120 calls daily in a high volume call center with up to 4,000 daily.• Trained all new hires including CSR’s and management in all aspects of day to day responsibilities.• Processed daily credits, refunds, rebate, and return inquiries.