Quality Assurance Operations Specialist

At Telix Pharmaceuticals, we are a leading and rapidly expanding radiopharmaceutical company, with our headquarters in Australia and additional offices in Belgium, Japan, Switzerland, and the United States. Our mission is to fulfill the promise of precision medicine through targeted radiation therapies. We are dedicated to developing innovative products that enhance the lives of individuals battling cancer and rare diseases. As a crucial member of our team, you will play a vital role in the global launch of our prostate cancer imaging agent and contribute to advancing our portfolio of late-stage clinical products aimed at addressing urgent needs in oncology and rare diseases.Join Us at TelixThe Quality Assurance Operations Specialist will oversee quality-related initiatives and projects in their designated area, ensuring compliance with GxP standards and adherence to the IsoTherapeutics Quality Management System at our Angleton, TX manufacturing facility.Key Responsibilities:Oversee quality assurance within all manufacturing, quality control, and supply chain operations to ensure strict compliance with current Good Manufacturing Practices (cGMP). Promptly escalate any deviations to management.Conduct live reviews of manufacturing batch records in preparation for batch releases, immediately addressing any discrepancies.Collaborate with various teams to ensure timely and compliant final product dispositions for manufactured products.Ensure site personnel adhere to aseptic techniques and comply fully with sterile manufacturing regulations.Support FDA and regulatory interactions concerning Angleton site activities and products, facilitating successful regulatory submissions and inspections.Act as a trusted partner in QA Operations, fostering a culture of safety, quality, and integrity in data and compliance.Assist in managing compliance-related exceptions across departments, ensuring timely resolutions.Perform additional related tasks as assigned.

Join Spark Power as a Substation Operator!As a leading partner in the energy sector across North America, Spark Power is seeking a dedicated Substation Operator to enhance our operations in Angleton, TX.In this pivotal role, you will manage critical field-based switching operations, isolate transformers, evaluate relay trips, execute Lockout/Tagout (LOTO) procedures, and perform both preventive and corrective maintenance. You will also troubleshoot equipment and work closely with the ROC to coordinate substation re-energization efforts.Key Responsibilities:Substation Switching & Isolation: Conduct safe and systematic switching operations, isolating and energizing transformers, circuit breakers, and other high-voltage apparatus in accordance with established protocols.LOTO & Safety Compliance: Enforce and implement LOTO procedures to safeguard personnel during maintenance tasks.Relay Trip Assessments & Fault Analysis: Analyze relay trips to pinpoint fault causes, collaborating with system operators and relay technicians for effective resolution.Troubleshooting & Equipment Maintenance: Perform diagnostic checks on substation components, including breakers, transformers, relays, and control systems.Substation Re-energization Support: Work with remote operators and field teams to ensure safe power restoration following maintenance or fault conditions.Monitoring & Inspection: Conduct regular inspections of substation equipment to ensure operational readiness and mitigate potential hazards.Emergency Response & Outage Restoration: Respond promptly to unexpected outages, implement corrective measures, and assist in the safe restoration of power.Collaboration with Remote Teams: Collaborate with the ROC, SCADA operators, engineers, and maintenance teams to uphold system reliability.Client Interaction: Foster professional relationships with field clients, addressing concerns and escalations as necessary.Documentation & Reporting: Maintain comprehensive records of switching operations, relay events, equipment conditions, and maintenance activities.

Join Telix Pharmaceuticals, a trailblazing radiopharmaceutical company headquartered in Australia, with additional offices in Belgium, Japan, Switzerland, and the United States. Our vision is to revolutionize precision medicine through targeted radiation, aiming to enhance the quality of life for individuals battling cancer and rare diseases. In this role, you will play a pivotal part in the international deployment of our prostate cancer imaging agent and contribute to the advancement of our late-stage clinical products addressing critical gaps in oncology and rare disease treatment.Position Overview:The Scientist II in Analytical Chemistry will play an essential role in supporting the IsoTherapeutics Group’s radiochemistry laboratory. You will be instrumental in the development, validation, and technical transfer of analytical methods crucial for radiopharmaceutical manufacturing. Your responsibilities will include executing and validating non-microbiological quality control assays, such as HPLC, Radio-TLC, immunoreactivity testing, and other related analytical techniques.This position requires routine handling of radioactive materials and adherence to a GMP-regulated environment, with a strong emphasis on data integrity, compliance, and method robustness. The Scientist II will collaborate closely with cross-functional teams to ensure manufacturing readiness and that analytical methods align with both regulatory and operational requirements.Key Responsibilities:Quality Control: Perform analytical testing (e.g., HPLC, TLC, spectroscopy) to assess the quality and purity of radiopharmaceutical products.Analytical Method Transfer: Lead or assist in the technical transfer of analytical methods from external vendors into GMP-compliant practices at IsoTherapeutics Group.Experimental Design and Execution: Design, conduct, and document experiments to meet research objectives while adhering to project timelines.Regulatory Compliance: Ensure compliance with safety protocols, radiation safety guidelines, Good Laboratory Practices (GLP), and other regulatory standards.Instrumentation Maintenance: Operate, calibrate, and maintain laboratory instruments to guarantee reliable and accurate results.Data Analysis and Reporting: Analyze experimental data, interpret findings, and prepare technical reports and presentations for internal and external stakeholders.