Strategic Development QA Leader (Onsite)

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

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.