AMANDA N. BROCK

Special Projects:

• Assist the CORE team of materials engineers with nozzle coating project. Project involves pinpointing an optimal polymer coating formulation within nozzles used for IOL delivery devices.

Continuous improvement projects performed:

• Create a training metrics spreadsheet to keep track of every Pilot Line employees' skillsets.
• Help transition department into utilizing electronic laboratory notebooks for environmental monitoring.
• Optimize ordering and inventory processes by creating a centralized ordering system for entire department.

Daily job roles:

• Provide support for engineers in the development, testing, modification, and improvement of products and processes within IOL Pilot Line
• Experience handling and formulating polymers for IOL lens development
• Utilize various equipment and software to gather data for medical device development core projects
• Communicate with other departments on project needs and priorities
• Effectively manage time with daily lab duties as well as with ancillary projects
• Abide by ISO/GxP/ANSI/FDA standards and guidelines

• Responsible for testing implementation, data support, product expertise, and method optimization for developmental and finished products
• Carryout high quality testing by following FDA, ISO, GDP/GLP/GMP, and ICH guidelines
• Proficient with Agilent HPLC/UPLC/GC and Waters instrumentation, the Cary FTIR and UV/VIS, Osmometer, Soxhlet Extraction, and Milestone UltraWave
• Manage several projects at any given time, manage project priority, and ensure they are complete by deadlines
• Experience with data acquisition and analysis using Empower, BIOVIA eLNs, and LabVantage8 MD LIMS software
• Write technical protocols and chemical characterization reports for developmental projects
• Coordinate and perform testing for pilot line, lens products, and IOL surgical products to support both stability and development projects
• Effectively communicate with other team members or departments on in-process and future testing progress, and help train incoming contract employees
• Created spreadsheets and other forms of documentation to accurately record and calculate analytical results

• Carry out high complexity testing with AB Sciex LCMS and AU400 analyzers and follow strict procedures
• Utilize Analyst Chromatography Data System software (CDS)
• Calibrate, maintain, and troubleshoot equipment on a daily basis
• Perform intensive validations on new equipment and methods
• Communicate with FSE's and vendors regularly
• Follow SOP's and adhere to CLIA and COLA regulations as well as prepare for annual audits and CAP testing
• Effectively communicate with management and lab directors
• Process and prepare patient samples for bio-analytical testing
• Thoroughly review patient results before consolidating paperwork for billing
• Create procedures for laboratory workflow and organization.

• Use analytical instruments such as HPLC, FTIR, GC, Dissolution and have in depth knowledge of Chromeleon CDS software
• Perform analytical tests on in-process and finished products to ensure they meet specified requirements for production
• Develop new methods for testing as well as implementing method transfers
• Write SOPs, technical protocols, and technical reports
• Experience with USP, (V)ICH, CFR, and FDA regulations
• Work in a team environment as well as managing individual projects
• Properly communicate to management about current and future projects
• Troubleshoot testing or equipment issues and coordinate with Vendors for maintenance
• Research incoming APIs to determine appropriate methods to develop for testing and formulation.

• Perform various laboratory tests such as blood typing, leucocyte counts, and PCR and antibody detection to screen specimens for viruses
• Experience with Quality Control for various products before using them in
• Specimen testing
• Follow CLIA regulations, cGMPs, and SOPs for both job performance and preparation for FDA and AABB audits
• Experience with PRISM, TIGRIS, PANTHER, ProVue, and Quickstep analyzers
• Perform PQs on instruments and eligible reagents
• Troubleshoot and repair analyzers when issues arise; communicate with field engineers as necessary
• Utilize Laboratory Information System and Excel daily to track any missing samples, determine results, and generate various reports
• Extra activities: Member of the Safety Committee and an Operational Xcellence program that teaches Lean Six Sigma practices.