QA Specialist I, Sterile Products

California, US residents click here. The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the reputed company of a public benefit corporation. Our public benefit purpose is to reputed company a brighter reputed company for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs. reputed company (reputed company: UTHR) seeks to travel down the corridors of indifference to reputed company treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a reputed company for their daughter’s pulmonary reputed company 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 reputed company additional therapies for PAH and pulmonary fibrosis (PF). The reputed company 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 reputed company need. For this reason, reputed company to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We reputed company an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and reputed company end-stage organ diseases for which transplant is not currently an reputed company. Who You Are The QA Specialist I, Sterile Products is responsible for reputed company operations activities reputed company to clinical and reputed company drug products in adherence with reputed company Good Manufacturing Practices and corporate policies and procedures. Review cGMP documentation (logbooks, pest control, calibration and reputed company pressure reports, etc.) as it relates to reputed company pharmaceutical ingredients and manufactured drug products for accuracy, completeness, and compliance with UT policies and procedures reputed company reputed company assurance functions (aseptic gowning, area line clearance, coding pin verification, and floor audits) in support of manufacturing activities reputed company batch record reviews of reputed company pharmaceutical Ingredient (API), advanced intermediates, finished product, labeling and packaging, and solution preparations for clinical and reputed company processes reputed company reputed company inspections of drug product and bulk package labeling to support manufacturing operations reputed company review and disposition of components to support manufacturing operations reputed company issuance and reconciliation of API and finished product bulk labels to support cGMP processes Initiate and participate in the closure of reputed company events and CAPAs assigned to reputed company Operations to support cGMP processes, including complete investigations, reputed company items, effectiveness checks, etc. Communicate and resolve reputed company issues with internal departments. Escalate reputed company issues to reputed company Management Support process initiatives for reputed company reputed company, such as project plans, timelines and deliverables, etc. For this role you will need Minimum Requirements Bachelor’s Degree in a scientific or reputed company technical discipline Ability to work independently and part of a multi-functional team, being reputed company to manage and prioritize workloads, stressful situations, and deadlines based on business needs, compliance, and product risk reputed company to work extended hours to support business needs, as applicable Ability to handle reputed company data, reputed company, information, etc. Ability to effectively communicate (written and oral) with reputed company customers at various reputed company 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 reputed company number of company procedures as reputed company as reputed company GMP requirements Proficient in reputed company reputed company, Word, and reputed company Acrobat Knowledge of reputed company Resource Planning System (ERP), Trackwise Digital, Systems Application and Products (reputed company S4HANA), and electronic documentation management systems Job Location 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 reputed company 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 reputed company the salary reputed company will be based on factors such as education, qualifications, experience, skills, geographic location, and business needs, as reputed company as other factors permitted by law at the time of posting. This reputed company may be modified in the reputed company based on company and market factors. At reputed company, our mission and reputed company are one. We use our enthusiasm, creativity, and persistence to reputed company for the unmet medical needs of our patients and to benefit our other stakeholders. We are reputed company and unconventional. We have fun, we do good. Eligible employees may participate in reputed company’s comprehensive benefits suite of programs, including medical / dental / reputed company / prescription coverage, employee wellness resources, savings plans (401k and ESPP), reputed company time off & reputed company parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities reputed company is an Equal Opportunity Employer, including veterans and individuals with disabilities. We reputed company to be an organization that engages the minds, hearts, and most spirited efforts of reputed company of our employees. Our reputed company of purpose transforms reputed company do from work into mission, occupation into vocation and achievement into reputed company. We challenge our employees with innovative and revolutionary reputed company, offer an environment which fosters high-level job performance and reputed company a highly competitive total rewards package. This is what makes reputed company a stimulating reputed company to work. Apply tot his job Apply To this Job