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.

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.

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.

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.

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.

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.

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.