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Qa Specialist Ii - Document Control

Company

United Therapeutics
Address , Silver Spring
Employment type FULL_TIME
Salary
Expires 2023-10-11
Posted at 8 months ago
Job Description
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 QA Specialist II - Document Control will be responsible for processing and managing documents from initiation to release in the MasterControl eDMS to ensure adherence to regulatory requirements and current site practices in support of clinical and commercial manufacturing. This person will be responsible for issuing batch records, worksheets, logbooks, and other requested documents to support an array of departments such as QC, Manufacturing, and Quality Assurance. Additionally, this person will be responsible for scanning and physically filing executed documents / records to their respective designated locations. This person will also maintain the document archive rooms to ensure records are preserved, organized, structured, retrievable and accessible in a timely manner. Other duties will include preparing and indexing records to be archived off-site and support projects as assigned.

  • 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
  • Prepare, review and issue production batch records, worksheets, logbooks, and other requested GxP 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
  • Provide support related to documentation as needed
  • Assist with Document Control projects as it relates to system configuration, process improvements, efficiency, etc.
  • May participate in cross-functional project teams as a department representative
  • Foster a culture of collaboration, partnership, teamwork, and a drive for change and continuous improvement
  • Manage the life cycle of controlled documents in the electronic document management system (document creation, revision, archival, retention and withdrawal/retirement)
  • Process and execute documents undergoing Document Change Control (assignment, tracking, closure) to ensure adherence to regulatory requirements and current site practices
  • Maintain document archival, retrieval and destruction of records at off-site storage per cGMP regulations
  • Ensure the proper distribution of and access to approved documents, and maintain controlled documents
  • Provide support with regulatory audits and inspections as required
  • Perform all other duties as required
  • Support or implement the document periodic review process
  • Administer the MasterControl electronic Document Management System

For this role you will need
Minimum Requirements
  • Experience using a document management system preferably MasterControl experience
  • Demonstrated ability to perform detail-oriented work with a high degree of accuracy
  • Proactive, shows initiative, with excellent organizational and planning skills
  • Effective time management and interpersonal skills
  • Builds productive internal and external working relationships
  • 2+ years of experience in using an electronic document management system (eDMS) preferably MasterControl
  • Bachelor’s Degree in Arts/Sciences (BA/BS) in science, technical, or related discipline
  • 2+ years of experience in Document Control and/or Quality Systems fundamentals
  • Knowledge of understanding of Document Control standards, practices, and principles
  • Effective written and oral communication skills
  • 2+ years of experience in a FDA regulated industry, such as pharmaceutical, medical device, biotech, etc.
  • Knowledge of understanding of Quality Systems and applicable GMP regulations and standards
  • Must work effectively within teams with rapidly changing priorities
  • Knowledge of the Microsoft suite (i.e. Word, Excel, Visio, PowerPoint, etc.) and Adobe
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