Senior QA Specialist, Strategic Development

California, US residents .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, 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 batches

Perform review of quality control final product, combination product release and stability data Communicate with Quality Assurance, Quality Control, Regulatory Affairs, Strategic Clinical Development, and other departments as needed to complete Quality related tasks

Collaborate and support quality events, CAPAs and change controls, as assigned, to support cGMP processes

Create and revise standard operating procedures (SOPs) and work instructions

Participate in CMC product development activities/meetings as it relates to Quality work

Work 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 assigned

Collaborate closely with Strategic Development Quality management to ensure critical project timelines are met Assess, review, and adjudicate temperature excursion events related to Clinical Trial Material (CTM) and Clinical Retain Samples (CRS)
Other related responsibilities as assigned

Minimum Requirements

Education and Experience requirements:

Bachelor’s degree in science/engineering, and 5+ years of relevant pharmaceutical industry experience in a cGMP environment, or Master’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 risk Experience in review of batch records

Ability to interpret technical data in relation to applicable procedures/specifications as…