QA Specialist II, Quality Operations (Combination Products)

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The job details are as follows:

Who We Are

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.
Who You Are

The QA Specialist II, Quality Operations is responsible for quality operation activities related to clinical and commercial drug products in adherence with current Good Manufacturing Practices (cGMP) and corporate policies and procedures at the RTP campus.

• Review GMP documentation, including, logbooks, pest control, waterlogs, calibration and maintenance reports, temperature monitoring, batch records, protocols, etc. as it relates to Combination products for accuracy, completeness, and compliance with UT policies and procedures
• Perform quality assurance functions, including inspection of production equipment for cleanliness, gowning, area line clearances, in-process packaging checks, AQL inspections and floor audits, in support of manufacturing and packaging activities
• Perform the review and disposition of manufacturing, packaging and Combination Products batch records and components for clinical and commercial processes
• Perform review of quality control final product data
• Process rejected lots of raw materials, components and Combination products identified for destruction
• Process retention samples and Combination products identified for storage
• Perform labeling activities, including incoming inspection, issuance, cycle counts, SAP transactions and reconciliation of labeled and printed components
• Create and revise standard operating procedures (SOPs) and work instructions
• 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.
• Provide Combination products data for annual quality reviews (AQR)
• Communicate and work closely with internal and external partners to resolve quality issues. Escalate complex issues to Quality Management.
• Support process initiatives for quality projects, such as project plans, timelines and deliverables, etc.

Minimum Requirements

• Bachelor’s Degree in a scientific or related technical discipline
• 2+ years of relevant pharmaceutical industry experience in a cGMP regulated environment
• Ability to work independently and as part of a multi-functional team, being able to manage and prioritize workloads, stressful situations, and deadlines and work extended hours to support business needs
• Able to work extended hours to support business needs, as applicable
• Ability to effectively communicate with internal customers at various levels in the organization; written and oral
• Ability to handle confidential company data, projects, information, etc.
• Ability to interpret data in relation to a vast number of company procedures as well as current GMP requirements
• Experience in review of batch records, production records, process control records
• Proficient in Microsoft Excel, Word, and Adobe Acrobat

Preferred Requirements

• 2+ years of experience in combination products
• Knowledge of Enterprise Resource Planning System (ERP), TrackWise Digital, Systems Application and Products (SAP S4HANA), and MasterControl

Job Location

United Therapeutics requires this candidate to be on-site at our RTP, North Carolina location 100% of the time.

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. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities

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