Angela Starner Email & Phone Number

Fort Collins, Co, Us

Windsor, Colorado, United States

▪ Conducted thorough technical reviews and delivered final approvals for protocols to qualify a newly constructed Sterility Laboratory, ensuring compliance with regulatory standards and relevant GxPs.▪ Leveraged extensive industry expertise to provide meticulous Quality Assurance oversite offering reviews and approvals for various Controlled Drawings, Equipment Qualifications, Process Validations, SOPs and Change Controls.

Windsor, Colorado, United States

▪ Dedicated validation representative in six successful global regulatory and marketing partner inspections, offering integral front and back-room support. ▪ Proficient in adeptly engaging with inspectors and swiftly locating pertinent documentation for presentation, ensuring streamlined interactions.▪ Demonstrated technical leadership and empathy-driven guidance while managing a team of eight validation engineers through multiple high-priority projects and routine requalifications. ▪ Leveraged a supportive approach to empower cross functional teams, fostering a collaborative environment that ensured each individual was working toward the same goal.▪ Actively engaged as a 'working manager,' performing validation engineer and individual contributor tasks to support team efforts in meeting project timelines.▪ Managed all facility, utility, equipment, and system (FUES) validation activities including: Grade A through Grade D processing facilities, vial filling lines, syringe assembly machines, compounding equipment, packaging equipment, sterilization equipment (steam, dry heat, and VHP), laboratory equipment, controlled temperature units (CTUs), etc.▪ Lead the effort to qualify new equipment utilizing a risk-based approach, leveraging basic functional testing from engineering activities such as FAT and SAT to cut final validation timelines in half.

Windsor, Colorado, United States

▪ Presented previous audit responses and qualification documents to FDA personnel during two routine GMP regulatory audits.▪ Lead a team of three validation engineers to qualify packaging equipment for a new production presentation including syringe assembly robots, tray sealer, tray labeler, cartoner, and checkweigher.▪ Managed the validation effort to bring an existing manufacturing suite back into service after extended shutdown.▪ Mentored two entry level engineers, assisting with goals and career development.

Windsor, Colorado, United States

▪ Authored sections of Sterility Assurance regulatory filing documents for a new product approval.▪ Qualified a new steam control system to automate SIP processes on aseptic compounding and filling tanks. ▪ Completed aseptic process simulation / media fill protocols and reports.▪ Acted as team lead to mentor and on-board new hires, cross-train team members, and divvy up project work. ▪ Acted as the audit back-room validation SME during a successful PAI for new product approval.▪ Lead the validation effort of adding Dehumidification units to Grade B processing areas.▪ Worked with an over-arching cross-functional team to complete an extensive design review of a new Powder Filling Isolator line, tying User Requirements to design documents.▪ Managed change control completion for new product launches, new equipment installations, and facility changes.

Windsor, Colorado, United States

- Completed SIP qualifications for specialty injectable compounding equipment including a Pharmaceutical Wet Mill and Bulking/Filling Tanks - Executed steam sterilization cycle validation and annual requalification activities on production and laboratory autoclaves, ensuring EN285 requirements were met - Composed incident root cause analysis investigations and completed appropriate CAPA actions- Retrofitted an existing laboratory autoclave to be able to complete temperature mapping studies, including installing a new controlling RTD probe and thermocouple pass-thru.- Contributed in the closure of internal and external audit findings- Authored and executed IQ/OQ/PQ for various systems including a new refrigerated truck, depyrogenation ovens, temperature controlled chambers, production lyophilizers, and laboratory hoods.- Managed change control completion for new product launches, new equipment installations, and facility changes.- Completed smoke studies on multiple RABS filling lines. - Assisted in equipment shakedown and troubleshooting

New Albany, Ohio

- Completed the cycle development and performance qualification (PQ) activities for new steam sterilization autoclaves- Presented autoclave qualification (IQ, OQ, PQ) reports to FDA inspectors during the successful PAI of a new production facility - Executed vaporized hydrogen peroxide (VHP) sterilization cycle validation and annual requalification activities on production and laboratory isolators- Attended the factory acceptance test (FAT) for a new water cascade sterilizer utilized for terminal sterilization activities- Managed the installation and on-site vendor qualification (SAT, IQ/OQ) of the water cascade terminal sterilizer, acting as the liaison between the vendor and production staff - Performed terminal sterilization cycle development studies, determining the best possible heat time, dwell duration, pressures, ramp rates, and cool time for multiple products- Authored and executed sterilization performance qualifications and annual requalifications on aseptic process equipment, including autoclaves, terminal sterilizers, dry heat depyrogenation tunnels, and sterilization-in-place (SIP) equipment- Trained team members on use of validation testing equipment and procedures- Managed the closure of internal audit observations- Assisted in equipment and utility shakedown and troubleshooting

Indianapolis, Indiana

- Completed monthly utility trending reports, including analyzing trends in alarm and excursion data- Performed periodic reviews of GMP equipment and utilities including purified water, compressed air, and various production and packaging line equipment- Authored and executed commissioning and qualification (IQ, OQ, PQ) packages for a variety of equipment, facility, and utility changes (e.g. bottle labeler, vision system, tablet press equipment, metal detectors, parts washer, bin charging system, facility modifications, air handlers, compressed air, purified water, process area monitoring, network controllers)- Managed multiple projects and budgets, including presenting monthly status reports to the client, writing new project proposals, and authoring scope changes.- Facilitated Dry Pharmaceutical product recovery systems by authoring inspection and return-to-bulk protocols to resolve packaging line events- Developed and executed temperature mapping protocols for GMP areas- Updated Dry Products Site Master Filer per FDA and PIC/S guidance to prepare for upcoming audit

Indianapolis, Indiana Area

- Worked alongside a team of three engineers during the development of a set of surgical power tools for scoliosis related applications.- Responsible for the development and execution of motor life cycle testing- Researched new materials, assembly tools and testing equipment for use during product development - Designed assembly fixtures to reduce the time of product assembly, lowering overall production costs