QA Specialist I, Sterile Products

QA Specialist I, Sterile Products

We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.

United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).

The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.

The QA Specialist I, Sterile Products is responsible for quality operations activities related to clinical and commercial drug products in adherence with current Good Manufacturing Practices and corporate policies and procedures.

• Review cGMP documentation (logbooks, pest control, calibration and differential pressure reports, etc.) as it relates to active pharmaceutical ingredients and manufactured drug products for accuracy, completeness, and compliance with UT policies and procedures
• Perform quality assurance functions (aseptic gowning, area line clearance, coding pin verification, and floor audits) in support of manufacturing activities
• Perform batch record reviews of active pharmaceutical Ingredient (API), advanced intermediates, finished product, labeling and packaging, and solution preparations for clinical and commercial processes
• Perform Quality inspections of drug product and bulk package labeling to support manufacturing operations
• Perform review and disposition of components to support manufacturing operations
• Perform issuance and reconciliation of API and finished product bulk labels to support cGMP processes
• Initiate and participate in the closure of quality events and CAPAs assigned to Quality Operations to support cGMP processes, including complete investigations, action items, effectiveness checks, etc.
• Communicate and resolve quality issues with internal departments. Escalate complex issues to Quality Management
• Support process initiatives for quality projects, such as project plans, timelines and deliverables, etc.

For this role you will need

• Bachelor's Degree in a scientific or related technical discipline
• Ability to work independently and part of a multi-functional team, being able to manage and prioritize workloads, stressful situations, and deadlines based on business needs, compliance, and product risk
• Able to work extended hours to support business needs, as applicable
• Ability to handle confidential company data, projects, information, etc.
• Ability to effectively communicate (written and oral) with internal and external customers at various levels in the organization

Preferred Qualifications

• 1+ years of relevant pharmaceutical industry experience in a cGMP regulated environment
• Ability to interpret data in relation to a vast number of company procedures as well as current GMP requirements
• Proficient in Microsoft Excel, Word, and Adobe Acrobat
• Knowledge of Enterprise Resource Planning System (ERP), Trackwise Digital, Systems Application and Products (SAP S4HANA), and electronic documentation management systems

This hybrid role is located in Silver Spring, MD and requires reporting to the office at least three days a week. In office requirements could increase based on business needs.

The salary range for this position is $64,000- $85,000/yr and reflects our good-faith estimate of the compensation for this role at the time of posting. An employee's position within the salary range will be based on factors such as education, qualifications, experience, skills, geographic location, and business needs, as well as other factors permitted by law at the time of posting. This range may be modified in the future based on company and market factors.

At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.

Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more.

United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.