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Senior QA Specialist, Quality Operations (Combination Products)

United Therapeutics

Research Triangle Park, NC

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JOB DETAILS
SKILLS
Adobe Acrobat, Alliance/Partner Marketing, Biotech and Pharmaceutical, Business Skills, Business Support, Calibration, Cancer, Change Control, Check Processing, Communication Skills, Corporate Policies, Cross-Functional, Current Good Manufacturing Practice (cGMP), Disease, Documentation, Drug Development, Drug Products, ERP (Enterprise Resource Planning), Establish Priorities, FDA (Food and Drug Administration), FDA Requirements, GMP (Good Manufacturing Practices), Internal Audit, Manufacturing, Manufacturing Operations, Microsoft Excel, Microsoft Word, Operational Audit, Operational Support, Organ Transplant, Organizational Skills, Pediatrics, Performance Metrics, Pest Control, Problem Solving Skills, Process Control Engineering, Process Development, Product Support, Production Schedule, Project Planning, Pulmonary Disease, Quality Assurance, Quality Control, Quality Management, Realtime Transport Protocol, SAP, Software Validation, Standard Operating Procedures (SOP), Standards Development, Supply Chain, Test Scripts, Time Management, Training/Teaching, Validation Testing
LOCATION
Research Triangle Park, NC
POSTED
10 days ago
California, US residents click here (https://www.unither.com/docs/UNITHER%20Applicant%20Notice%20-%20%2812-22-23%29%20Final%202.15.24%20Combined%20EN%20and%20French.pdf#page=9) . **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 Senior QA Specialist, 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 facility. + 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 operations + Review and disposition manufacturing, packaging and Combination Products batch records and raw materials and components for clinical and commercial processes + Review of quality control final product and stability data + Process rejected lots of raw materials, components and Combination products identified for destruction. + Process retention samples and Combination products identified for storage + Create and revise standard operating procedures (SOPs) and work instructions + Initiate and participate in the closure of quality events, CAPAs and change controls 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) + Conduct Quality Operations training for the Quality Team as it relates to cGMP Activities. Review peer work assignments, as applicable. + Communicate key performance indicators and metrics to Quality Management related to Combination products processes + Develop process initiatives for Quality projects, such as create project plans, timelines and deliverables, etc. + Participate in site cross functional projects (software validation, test scripts, project planning, etc.) to ensure a harmonized approach across the organization + Works independently to interpret data and solve complex quality issues with minimum guidance with internal and third- party partners. Escalate unresolved issues or concerns to Quality Management and affected area management + Participate in client meetings and projects as it relates to manufacturing, product scheduling, batch records, supply chain, etc. to support product pipelines + Support regulatory authority (FDA, MHRA, EMA, QP, etc.) inspections and internal audits, including documentation audit team, pre-audit facility inspections, etc Minimum Requirements + Bachelor’s Degree in a scientific or related technical discipline + 5+ years of relevant pharmaceutical industry experience in a cGMP regulated environment + Ability to work independently and 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 + Experience in review of batch records, production records, process control records + Ability to interpret data in relation to a vast number of company procedures as well as current GMP requirements + Ability to effectively communicate (written and oral) with internal and external customers at various levels in the organization + Ability to handle confidential company data, projects, information, etc. + Proficient in Microsoft Excel, Word, and Adobe Acrobat Preferred Requirements + 2+ years of experience in combination products + Ability to interpret multi compendia documentation (USP/EP/JP) + 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. _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 job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work._

About the Company

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United Therapeutics