California, US residents click here.
The job details are as follows: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 well as phase appropriate current GMP requirements
- Ability to handle confidential company data, projects, information, etc.
- Ability to effectively communicate (written and oral) internally and externally at various levels in the organization
- Proficient with Microsoft Office and Adobe Acrobat applications
- Knowledge of GxP systems (Trackwise, MasterControl, Veeva Vault) and SAP
Preferred Qualifications
- Master's degree in science/engineering
- Experience with combination products
- Familiarity with regulatory guidance documents
Job Location
United 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.
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
