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. 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 Senior QC Specialist is responsible for completing raw material certificate review and disposition as well as intermediary and product test results review. This position also supports QC testing of raw materials, intermediates, and product. This is an on-site role.
- Review and approve test results for raw materials, intermediates, and product
- Manage and lead OOS investigations, participating as needed, and ensure timely completion
- Author stability plans and reports and coordinate testing to ensure timely completion
- Lead QC support for raw materials process, including certificate review and any testing
- Coordinate testing activities across the team
- Perform method transfer, method qualification, and validation activities
- Author and approve SOPs, test methods, and technical protocols and reports
- Coordinate activities for routine monitoring of the autoclave and EtO processes and the release of internally sterilized materials
- Own relevant deviations and change controls
- Assemble QC metrics package
- Support QC testing of raw materials, intermediates, and product according to established procedures and GDP (Good Documentation Practices) as needed
Minimum Requirements
For this role you will need
- Bachelor’s Degree in biology, microbiology, or related field
- 5+ in a similar quality control role
- 3+ experience in an FDA regulated industry, preferably in biotech or pharma
- Experience with stability studies and method transfer and validation
- Experience completing OOS investigations
- Excellent attention to detail; strong time management and organizational skills
- Excellent oral and written communication skills, strong problem-solving ability, critical thinking, initiative, and interpersonal skills
Preferred Qualifications
- Experience developing strategy for environmental monitoring in an aseptic manufacturing environment, method validation, or stability studies
- Experience authoring stability plans and reports
- Experience developing strategy for validation of methods and/or design of stability studies
- Experience with LIMS
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
