Job details
Job type full-time
Full job description
United therapeutics is a vaccinated work environment where all employees are expected to be vaccinated against covid-19 and provide proof of vaccinationWe will provide any accommodations as required by law.
The job details are as follows:
What we do
United therapeutics corporation focuses on the strength of a balanced, value-creating biotechnology modelWe are confident in our future thanks to our fundamental attributes, namely our commitment to quality and innovation, the power of our brands, our entrepreneurial culture and our bioinformatics leadershipWe also believe that our determination to be responsible citizens — having a positive impact on patients, the environment and society — will sustain our success in the long term.
We currently have five approved products on the market and a long-term mission of providing an unlimited supply of transplantable organs for those who need them.
Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening conditionShe sought to find treatment options and a cure for her daughter and patients like herWe are founder-led, and relentless in our pursuit of “medicines for life”We continue to research and develop treatments for cardiovascular and pulmonary diseases, pediatric cancers and other orphan diseases.
How you’ll contribute
Establish and maintain compliant cgxp quality systems in support of medical device manufacturing and clinical useManage equipment and validation programs, design controls system, and perform quality and deviation management activities aligning with strategies and goals set by management.
Manage and maintain equipment files (physical and electronic) and on-going coordination of equipment preventive maintenance (pm) and calibration with internal and external service suppliers
Coordinate installation of new equipment and create equipment pm and calibration schedules
Serve as quality lead for the bluemountain ram (regulator asset manager) system in collaboration with quality/operations team
Work with operations staff to properly document all equipment-related events
Develop, coordinate, and execute process validation activities
Manage equipment qualification (development/execution of equipment protocols, and generation of reports)
Review and maintain site validation master plans (vmp) and validated systems
Manage (device) design controls system; develop standard operating procedures (sops), policies, and protocols in support of the design controls process
Develop and manage the design history files (dhf) in support of commercialization
Support efforts for continual improvements and needed design updates by leading all design control related change control activities
Perform quality event/deviation management activities, working with operations staff to conduct investigations for documentation of deviations, capas, and change controls
Coordinate trackwise work flows to ensure timely documentation and resolution
Responsible for facility environmental monitoring (em) program, including at least monthly review of em data (temperature, relative humidity, differential pressure, water testing, trends)
Manage em data trending for lung bioengineering (lbe) sites
Review documentation (i.e., analytical / medical records, clinical case records, protocols, reports, environmental monitoring data, device design history files, laboratory data, etc.) for accuracy, completeness, and compliance with lung bioengineering policies, procedures, and gmp/qsr/clinical trial requirements
Work with quality team to complete raw material inspection and release, document control and training functions and other qa activities
Work with internal and external partners to identify, develop, and execute on areas of improvement
Detect system gaps and coordinate resolution through constant surveillance
Provide real-time review of clinical case dataRequires 24/7 availability for procedure/data review (which can be done remotely)
Perform other duties as assigned
For this role you will need
Minimum requirements
Bachelor’s degree in arts/sciences (ba/bs) in engineering/science or other related/relevant area or equivalent relevant experience
3+ years of industry experience in quality assurance, quality engineering in medical device and/or pharmaceutical industry
Applied knowledge of gmps/qsr, fda guidelines, and industry standards
Ability to apply gmp to company-specific processes and products in the assessment and preservation of lungs
Strong attention to detail with excellent verbal, written, and professional documentation skills
Ability to convey complex issues objectively, accurately, and thoroughly in writing
Ability to produce a large volume of written materials independently
Demonstrated professional ability with problem-solving and risk analysis/assessments
Strong presentation and meeting facilitation skills
Ability to interpret data in relation to company procedures as well as current gmp/glp/gcp/qsr requirements
Ability to collaborate and communicate with other departments effectively
Ability to review work performed by other personnel, communicate problems and deficiencies, elicit corrections, and enforce company policy and procedures
Ability to handle confidential company data, projects, information, etc.
Proficient in ms office suite (word, excel, powerpoint, outlook)
Preferred qualifications
1+ years of experience using/managing a design controls program
Knowledge and use of trackwise
Knowledge and use of bluemountain ram (regulator asset manager) system
Knowledge and use of mastercontrol (edms)
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.
United therapeutics corporation is an equal opportunity/affirmative action employer - eoe minorities / females / protected veterans / individuals with disabilities
