Senior QA Specialist, Strategic Development

United Therapeutics Corporation; Silver Spring (MD); On-site; USD 93,000 - 125,000; Full time

Benefits offered by this job

Medical/dental/vision benefits

401k and ESPP

Paid time off

Parental leave

Job summary

United Therapeutics Corporation seeks a Senior QA Specialist, Strategic Development, to lead QA activities for clinical and IND/NDA materials in a 100% onsite setting at our Silver Spring, MD office.

You will review batch records and QC data, support CAPAs and change controls, and collaborate across QA, Regulatory Affairs and Development teams to ensure cGMP compliance and timely product delivery.

Qualifications

• Bachelor’s degree in science/engineering with 5+ years of cGMP experience
• Master’s degree with 3+ years of cGMP experience
• Ability to work independently and in a team, with strong time-management

Responsibilities

• Review and disposition executed batch records and related manufacturing/packaging docs for CTM/IND/NDA batches
• Review quality control final product, release and stability data
• Collaborate across QA, Regulatory, Strategic Development and other departments to complete quality tasks
• Participate in CAPAs, change controls and SOP/work instruction updates

Skills

Batch records review

Independent work

Attention to detail

Communication

GxP knowledge

Microsoft Office

Education

Bachelor's degree in science/engineering

Master's degree in science/engineering

Tools

TrackWise

MasterControl

Veeva Vault

SAP

Job description

California, US residents .The job details are as follows:Who We AreWe 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 AreThe Senior QA Specialist, Strategic Development is responsible for Quality Assurance activities related to Strategic Development programs in adherence with company policies and procedures, and phase appropriate current Good Manufacturing Practices (cGMP).Perform the review and disposition of executed batch records and associated manufacturing/packaging documentation for clinical trial material and IND/NDA supporting batchesPerform review of quality control final product, combination product release and stability dataCommunicate with Quality Assurance, Quality Control, Regulatory Affairs, Strategic Clinical Development, and other departments as needed to complete Quality related tasksCollaborate and support quality events, CAPAs and change controls, as assigned, to support cGMP processesCreate and revise standard operating procedures (SOPs) and work instructionsParticipate in CMC product development activities/meetings as it relates to Quality workWork independently to interpret data and solve complex quality issues with minimum guidance with internal and external partners. Escalate unresolved issues or concerns to Quality Management.Perform review of product development reports, method development reports, method validation reports, and other technical reports, as assignedCollaborate closely with Strategic Development Quality management to ensure critical project timelines are metAssess, review, and adjudicate temperature excursion events related to Clinical Trial Material (CTM) and Clinical Retain Samples (CRS)Other related responsibilities as assignedMinimum RequirementsEducation and Experience requirements:Bachelor’s degree in science/engineering, and 5+ years of relevant pharmaceutical industry experience in a cGMP environment, orMaster’s degree in science/engineering, and 3+ years of relevant pharmaceutical industry experience in a cGMP environment Will consider commensurate experience and/or combination of education and experience.Ability to work independently and part of a team, being able to manage and prioritize workloads, stressful situations, and deadlines based on business needs, compliance and product riskExperience in review of batch recordsAbility to interpret technical data in relation to applicable procedures/specifications as well as phase appropriate current GMP requirementsAbility to handle confidential company data, projects, information, etc.Ability to effectively communicate (written and oral) internally and externally at various levels in the organizationProficient with Microsoft Office and Adobe Acrobat applicationsKnowledge of GxP systems (Trackwise, MasterControl, Veeva Vault) and SAPPreferred QualificationsMaster’s degree in science/engineeringExperience with combination productsFamiliarity with regulatory guidance documentsJob LocationUnited Therapeutics requires this role to be 100% onsite in our Silver Spring, MD office.The salary range for this position is $92,500 - $125,000/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.#LI-DNIEligible 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-amenitiesUnited Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.