California, US residents click here. The job details are as follows: What We Do We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation. We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization. Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of “medicines for life”. We continue to research and develop treatments for cardiovascular and pulmonary diseases, and other orphan diseases. With over 100,000 patients on the organ transplant waitlist and only a fraction receiving the lifesaving organ they require, there is a great need for additional sources of transplantable organs. At Miromatrix, a leader in regenerative medicine and a subsidiary of United Therapeutics Corporation, we are working to address this unmet need by bioengineering human organs to help save and improve patients’ lives. Join our team as we continue to make history by developing life-saving therapies to help patients with liver and kidney disease. How you’ll contribute The QC Analyst II is responsible for completing QC testing in support of raw materials, intermediates, and product. This position will also perform routine monitoring of sterilization processes. Execute and peer review testing of raw materials, intermediates, and product according to established procedures and GDP (Good Documentation Practices) Execute testing for routine monitoring of the autoclave and EtO processes and release internally sterilized materials Support environmental monitoring activities, including sampling and reporting results Support routine monitoring of the USP water system, including sampling and reporting results Author/revise SOPs and methods Support management of samples and test results for external laboratory testing and coordinate result reporting Coordinate laboratory equipment calibration and maintenance activities Maintain laboratory supplies and conduct routine housekeeping activities Participate in out of specification investigations Participate in tech transfer, method qualification, and validation activities Support laboratory metrics For this role you will need Minimum Requirements Bachelor’s Degree in biology, microbiology, or related field 3 of relevant experience in a similar role 1 in an FDA regulated industry, preferably in biotech or pharma Knowledge of basic laboratory equipment Experience with GDP record keeping, preferably in a cGMP environment Experience with principals of aseptic techniques Excellent attention to detail; strong time management and organizational skills Ability to follow procedures as written with adequate documentation Excellent interpersonal skills, and ability to communicate effectively and collaborate cross-functionally Preferred Qualifications Experience with techniques/equipment such as qPCR, ELISA, cell counting, and flow cytometry At United Therapeutics you’ll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients. While United Therapeutics does not require vaccination for Covid-19 at this time, we strongly encourage all employees and visitors to remain up to date on vaccinations and boosters to protect one another from illness. Employees working in customer-facing roles must adhere and comply with customers’ credentialing guidelines, which may require vaccination against Covid -19, the influenza virus, and other illnesses that could be harmful to healthcare staff and patients. United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success. We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work.