QA Specialist I - Operations

United Therapeutics Corporation Durham , NC 27701

Posted 4 days ago

The Job Details are as follows:

What we do

About United Therapeutics

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 obsession with 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.

Through our wholly-owned subsidiary, Lung Biotechnology PBC, we are focused on addressing the acute national shortage of transplantable lungs and other organs with a variety of technologies that either delay the need for such organs or expand the supply. Lung Biotechnology is the first public benefit corporation subsidiary of a public biotechnology or pharmaceutical company.

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.

How you'll contribute

The QA Specialist I - Operations will provide support to the overall Quality Assurance program at the site. This individual will ensure that plant operations are within cGMP, local procedures, and corporate policies.

  • Adhere to and ensure compliance with company policies and procedures related to manufacturing and packaging

  • Serve as a direct, on-site contact for manufacturing personnel

  • Inspect production equipment for cleanliness to ensure it is prepared for future use

  • Perform QA functions (batch check-in, line clearance, in-process checks, etc) for manufacturing activities

  • Assist with deviation, containment, and CAPA processes for atypical manufacturing/packaging events under direction of QA Management

  • Participate in documentation management processes to include SOPs, APRs, batch records, protocols, and complaints as appropriate

  • Compile manufacturing data for drug products

  • Assist in product complaint investigations as applicable

  • Process rejected lots and product identified for destruction

  • Process retention samples

  • Review records (pest control, environmental monitoring, etc) as needed

  • Perform other duties as directed by manager

For this role you will need

Minimum Qualifications

  • Bachelor's degree, or an equivalent combination of education and professional experience
  • 1+ years of relevant pharmaceutical industry experience in a cGMP environment

Preferred Qualifications

  • Proficient in Microsoft Office Word, Excel, and Outlook

  • Prior experience working in solid dose/tablets, sterile fill, and packaging preferred

  • Working knowledge of U.S., FDA, EU and JP GMP regulations

  • Must be detail oriented, self-motivated, organized and have the ability to prioritize work

  • Must be able to work independently and as part of a multi-functional team, able to handle high workloads, stressful situation and deadlines.

  • Must be able to lift and carry up to 5-10 pounds throughout the day and on a regular basis

  • Must be able to stand and be mobile for long periods of time (production based environment)

Life as a Unitherian

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.

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 of job performance and provides state of the art facilities to flourish. This is what makes United Therapeutics a stimulating place to work.

United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities

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QA Specialist I - Operations

United Therapeutics Corporation