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The QC CRS Analyst is responsible for conducting biochemical and testing of raw material, in-process, final product release and characterization samples, including CAR-T. They are responsible for... More ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations. They typically work with a team of 5 -- 10 other Analysts within a functional Clinical Release and Stability Laboratory and report to the Senior QC Supervisor.Key Responsibilities:-Conduct analytical biological testing of clinical and commercial drug product/drug substance samples-Perform peer reviews and approvals of laboratory data-Use electronic systems (LIMS, MES, LES, Empower, etc.) for execution and documentation of testing including application of statistical concepts to laboratory data-Support of New Product Initiatives (NPI) including owning a project and perform project management functions with limited to no coaching from supervision/management -Perform Instrument Calibration and Preventative Maintenance-Update CRS-owned documents using the Document Management System (DMS) -Order/receive supplies and manage inventory-Support analytical method qualification, validation, and transfer into and out of the QC lab, owning change control actions, completing testing activities with mentorship from Sr. Analysts on transfer activities-Complete change control processes to integrate new methodologies and technologies into and out of the CRS Lab with limited oversight-Act as a peer subject matter expert in assessing talent by participating in panel interviews for job-Complete invalid assay and general laboratory investigation records-Complete corrective and preventative actions (CAPA) as assigned-Assist in the execution of internal auditsWe are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

An employer is seeing an Animal Care Tech II working in the RTC Lab for the Animal Medicine Department. You will be providing maintenance and support of research animal health under the direction of... More the veterinarian or study requirements.Key Responsibilities? Follow all safety and security policies during shifts by maintaining a working knowledge of applicable regulations and complying with all applicable SOPs/ WI documents, and other internal requirements.? Ensure that all appropriate regulations, procedures and data collection protocols are being followed throughout the course of a study.? Provide preventative care and maintenance care for all animal species. This may include performing weights, vaccinations, sample collections for clinical pathology, administering medications (all routes), and performing physical exams.? Provide support to the post operative chronic procedures by performing animal recoveries, conducting pain scores, entering post procedure cases on records, applying and removing bandages, maintain and collecting samples from indwelling catheters, administering medications including emergency drugs when needed, ability to use anesthesia machine, obtaining vitals on all species, and monitoring for any abnormal changes.? Ability to communicate clearly through documentation on the electronical medical record, emails, and verbal communications with the veterinarian.? Processing clinical pathology samples in house and sending samples accordingly to various labs? Ensuring all animal have adequate enrichment and social housing requirements? Clean and maintain assigned areas of lab by assisting with kennel and animal care as needed and communicating any animal health status issues to veterinarian and study director/sponsor.? Accurately maintain and backup all necessary records to ensure compliance with all applicable regulations, including animal treatment records, data forms, and drug logs, by carefully recording data, problems noted, resources consulted and action taken.? Coordinate inventory management with other lab staff by pursuing information on new/updated supplies and equipment with appropriate vendors and consulting with manager on any new supply/equipment issues.? Induce and maintain anesthesia, monitor physiologic status and take appropriate action for animals on acute or chronic studies.? Maintain up to date knowledge of all equipment, support instruments, test equipment, and routine and advanced veterinary techniques by consulting appropriate journals and attending appropriate training.? Maintain animal health throughout the study through consultation with veterinarian on diagnosis and treatment, administering prescribed therapy and monitoring response to treatment.? Perform pre-purchase physical and vaccination history examination and communicate the suitability of each shipment of animals to veterinarian and animal vendor.? May assist with/conduct necropsies under the direction of the veterinarian/pathologist, by properly labeling and documenting specimens, photographing gross pathology, coordinating histopathologic exams, and logging histopathologic reports immediately upon completion of necropsy.? May assist in pathology assessments by preparing, sending and receiving specimens to/from contract labs according to GLP guidelines.? May coordinate lab projects as directed by the manager by communicating the status of all ongoing projects regularly and coordinating the maintenance of all installed equipment in the lab facility.? Use extensive research experience to aid in study design and conduct. This may include making suggestions on study design, procedures, and protocols, planning and communicating study schedules, setting up and maintaining test equipment, interpretation of data, and record retention.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less