United Therapeutics is a vaccinated work environment where all employees are expected to be vaccinated against COVID-19 and provide proof of vaccination. We 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 model. We 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 leadership. We 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 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, pediatric cancers and other orphan diseases.
In 2021, we became 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.
How you’ll contribute
The QA Specialist I - Document Control will assist in the control, review, approval, distribution, and administration of the following: policies, standard operating procedures, controlled forms, batch records, specifications, test methods, label masters, worksheets, lab reports, and other controlled documents as necessary. Will issue batch records, worksheets, logbooks and other controlled documents as necessary. Additionally, will scan and file executed documents, maintain secured document file rooms, administer record management system, and process documents for review, approval, and distribution. Ensure compliance to applicable company policies, standards and regulations.
- Manage the life cycle of controlled documents in the electronic document management system (document creation, revision, archival, retention and withdrawal/retirement)
- Maintain control and maintenance of files in the Document Control room; Prepare & assist in document archival, retrieval and destruction of records at off-site storage per cGMP regulations; Ensure timeliness of record access and retrieval, identification, protection, and structure
- Ensure the proper distribution of and access to approved documents and maintain controlled documents
- Manage, store, and track GMP documents per current GMP regulations and internal procedures
- Prepare process and status reports, assign and monitor document numbers, and review documents for accuracy and completeness
- Work within the electronic document control system (MasterControl) to generate new or revise documents / procedures, when needed
- Implement related periodic documentation reviews
- Coordinate the review and revision of procedures, specifications, and forms
- Circulate proposed and final versions of proposed documents for review, coordinating with all appropriate departments to ensure correct departments are involved in the review and approval process
- Prepare, review and issue production batch records, worksheets, logbooks, and other requested GMP documents in accordance with company policies, quality systems and government regulations as directed
- Maintain the organizing, scanning, indexing, filing, storage and record keeping of GMP quality records (and other controlled documents as necessary) in compliance with company policy and regulatory standards
- Perform all other duties as required
For this role you will need
- Bachelor’s Degree in Arts/Sciences (BA/BS) or other relevant degree.
- 1+ years of relevant experience in a FDA regulated industry such as pharmaceutical, medical device, biotech, and etc.
- 1+ years performing in Quality or Document Control functions
- Hands-on knowledge with issuing GMP batch records, logbooks, and/or other controlled documents
- Excellent organizational skills and attention to detail
- Experience with eDMS/eQMS systems in pharmaceuticals and/or biotech (experience in MasterControl preferred)
- Knowledge of good documentation practices and procedures
- Working knowledge of GMP basics, FDA guidance, and industry best practices
- Ability to operate efficiently and effectively in a fast-paced environment
- Fulfill document requests in a timely manner
- Skilled in organization and date filing
- Laboratory Information Management System (LIMS) data review and retrieval
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