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California, US residents click here (https://www.unither.com/docs/UNITHER%20Applicant%20Notice%20-%20%2812-22-23%29%20Final%202.15.24%20Combined%20EN%20and%20French.pdf#page=9) .

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.

How you’ll contribute

The Quality Systems Specialist II will support Quality Systems and various support activities associated with QA oversight for UTC GMP operational activities, ensuring compliance with cGMPs, legal, regulatory, and UTC requirements. This includes supporting and/or facilitating but not limited to data analysis trending, gathering data for executive management review, participating/leading electronic system upgrades, etc. As an integral member of the Quality Systems team, this position maintains and continuously supports the improvements of all aspects of UTC's Quality Management System to ensure company and product compliance with applicable FDA regulatory and other agency requirements.

• Support and/or lead Quality Systems (such as Trackwise Digital, MasterControl, and LIMS) system upgrades and enhancements, as assigned

• Lead and/or support Quality Systems improvement initiatives, ensuring that processes meet UTC expectations and regulatory requirements

• Support UTC business units related to general use, evaluation of applicability of UTC Quality Systems to new processes, improvements and provide technical support as appropriate

• Assist in coordinating, gathering, preparing, and analyzing data for Management Review meetings

• Prepare and gather information to conduct mock recalls, as scheduled

• Report routine Quality System metrics related for areas of support such as Management Review, data trend analyses, periodic metrics reporting, etc.

• Lead and / or participate in routine system meetings such as LIMS, Change Control, etc.

• Prepare and conduct assigned Quality Systems training sessions to educate users on system use, reports, dashboards, and best practices

• Participate in internal audits, including implementation of responses and corrective actions

• Support regulatory inspections including site inspection preparedness activities such as audit initiation and follow-up activities

• Foster a culture of collaboration, partnership, teamwork, and a drive for change and continuous improvement

• Perform other duties as assigned

For this role you will need

Minimum Requirements

• Bachelor’s Degree in a science-based discipline

• 3+ years of experience in the biotech, pharmaceutical, medical device, biologics, or related regulated industry

• 3+ years of demonstrated experience of Quality Systems principles, practices, and processes such as CAPA, Change Control, Management Review, and Data Analysis

• Knowledge of Code of Federal Regulations (CFR) 210, 211, 820, Part 11, and/or other related FDA federal regulations and the ability to analyze regulations and apply them to Quality Systems and processes

• Ability to investigate, collect data, analyze for trends, and prepare reports for assigned quality processes

• Ability to work independently or lead projects working with cross-functional business team members

• Ability to to evaluate current Quality Systems and recommend improvements of quality system elements

• Knowledgeable or experience in using Quality Management System software applications such as Trackwise Digital, MasterControl, etc.

• Experience in using Microsoft Office Suite

• Knowledge of FDA and MHRA Data Integrity Guidance Documents

• Experience with Trackwise/Trackwise Digital, LIMS, and/or MasterControl systems

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.