Strategic QA Specialist Development & Compliance (Onsite MD)

Unither Pharmaceuticals; Silver Spring (MD); On-site; USD 93,000 - 125,000; Full time

Benefits offered by this job

Medical/dental/vision coverage

401k and ESPP

Paid time off & paid parental leave

Disability benefits

Job summary

United Therapeutics in Silver Spring, MD, seeks a Senior QA Specialist, Strategic Development to drive QA activities for CTM/IND/NDA programs in a cGMP environment. You will collaborate with QA, QC, Regulatory Affairs and Strategic Clinical Development to meet critical project timelines.

You will review batch records, release and stability data, develop and revise SOPs, and participate in development reports, CAPAs, and investigations with a focus on data interpretation and compliance.

Qualifications

• Bachelor’s degree in science/engineering with 5+ years in pharma cGMP
• Master’s degree in science/engineering with 3+ years in pharma cGMP
• Ability to work independently and in a team under deadlines
• Experience in review of batch records
• Ability to interpret technical data relative to GMP requirements
• Proficient with Microsoft Office and Adobe Acrobat
• Knowledge of Trackwise, MasterControl, Veeva Vault and SAP

Responsibilities

• Review and disposition of batch records and related documentation for CTM/IND/NDA batches
• Review quality control final product, release and stability data
• Coordinate with QA, QC, Regulatory Affairs and other departments on QA tasks
• Support CAPAs and change controls to maintain cGMP
• Create and revise SOPs and work instructions
• Participate in CMC development activities as they relate to QA
• Independently interpret data to resolve complex quality issues
• Review development and validation reports and other technical records

Skills

Batch records review

cGMP compliance

Data interpretation

Communication

Microsoft Office

GxP systems

Education

Bachelor’s degree in science/engineering

Master’s degree in science/engineering

Tools

Trackwise

MasterControl

Veeva Vault

SAP

Job description

United Therapeutics in Silver Spring, MD, seeks a Senior QA Specialist, Strategic Development to drive QA activities for CTM/IND/NDA programs in a cGMP environment. You will collaborate with QA, QC, Regulatory Affairs and Strategic Clinical Development to meet critical project timelines.

You will review batch records, release and stability data, develop and revise SOPs, and participate in development reports, CAPAs, and investigations with a focus on data interpretation and compliance.