Ed Starling Email & Phone Number

Bethesda, Maryland, United States

Hayward, CA

• Oversee design and management of the sterilization and aseptic manufacturing techniques and processes to provide Sterility Assurance for the manufacture of the company’s products as key member of MSAT team. Review and.
• Manage comprehensive sterilization validations for gamma irradiation and development of the verification dose audit program at service vendors as Sterilization Validation SME.
• Spearheaded complete overhaul of the gamma sterilization program, unifying all qualifications and closing gaps into a cohesive, standards-driven process. Coordinated all documentation for gamma irradiation validation.
• Serve as SME for Ethylene Oxide (EO) sterilization of kits, and implemented a comprehensive validation and testing program. Established sterilization coordination between contract manufacturer, contract sterilizer, and.
• Supplied NDA input for gamma sterilization methods and vendor qualifications for equipment, supplies, intermediate product parts, and medical devices.
• Represented Intarcia as the sterilization SME for gamma sterilization service vendor audits at Sterigenics, Corona and Hayward, CA, and Steris, Ontario, CA. Supplied input to final write-ups of vendor audit reports.

Hayward, California

• Managed the Sterilization Validation for both gamma and Ethylene Oxide gas sterilization. Developed the Facility Sterility Assurance group within medical products and assumed the SME role for the function, guiding CAPA.
• Served as Sterilization Validation SME, managing sterilization validations and verification dose audit program.
• Developed the Facility Sterility Assurance (FSA) function for the Baxter Medical Products facility, and facilitated communication between Regional Sterility Assurance function and the plant.
• Managed the Baxter Hayward facility Microbial Quality Control Plan to facilitate unified responses to sterility assurance issues across all departments in a timely manner.
• Performed vendor sterilization validation activities for terminally sterilized product versions in both gamma radiation and Ethylene Oxide (EO) gas sterilization. Qualified a new EO sterilization alternate vendor at.

Hayward, California, United States

• Performed QC microbiology lab testing and managed test method validation. Trained technicians in GMP and GLP.
• Wrote protocols and final reports for bioburden and endotoxin test methods for products from both Biologics and Medical Device business units.
• Consulted on the Tiger Team Environmental Monitoring (EM) investigation committee to bring microbiological expertise to the problem- solving task force.
• Addressed Baxter Corporate audit findings to benchmark the Hayward microbiology lab in Hayward with corporate-wide lab policy.
• Revised documentation for adoption of new laboratory procedures in a timely manner to maintain compliance with GMP/GLP requirements.

Hayward, California, United States

• Served as SME for vendor sterilization validation for the facility, and wrote and performed all new gamma irradiation and Ethylene Oxide gas sterilization validations, dose audits, and revalidations for both the.
• Performed as the SME for vendor sterilization validation. Assumed the writing and performance of all sterilization validation protocols for Floseal and Coseal product lines; completed all validations within projected.
• Conducted complaint investigations and documented results for review by management and Division complaint department.
• Validated the new HVAC system environmental requirements for the Medical Device Cleanroom addition, and wrote and coordinated the Performance Qualification of the Purified Water System addition.

Fremont And Hayward, California, United States

• Served as technical writer of equipment, and critical systems protocols, final reports and exception documentation.
• Performed and maintained validation work on terminal gamma irradiation and EO gas sterilization for new products.
• Presented overviews of the microbiology laboratory function during quarterly Management Review meetings.

Fremont, California, United States

• Supervised QC microbiology laboratory. Oversaw bioburden and endotoxin testing of process water, intermediate, and final products, EM of cleanrooms, microbial ID, and media preparation.
• Coordinated cleanroom EM qualifications, and qualifications of laboratory equipment; maintained laboratory documentation.

San Jose, California, United States

• Set up and managed Quality Assurance group to include the Quality Control Microbiology and Chemistry test lab, incoming materials receipt inspection, and manufacturing line inspection systems.
• Organized relevant personnel training, wrote SOPs, and represented Quality during FDA inspections.
• Performed steam sterilization and aseptic filling system validations.

Sunnyvale, California, United States

• Performed sterility testing, microbial limits testing, water sampling/testing, environmental monitoring, and media preparation.
• Developed sterility test failure investigation procedure.

Sunnyvale, California, United States

• Performed line inspections, finished product inspections, and incoming raw materials inspections.

Bachelor Of Arts (B.A.), Biology/Biological Sciences, General

Associate Of Science - As, Biology, General