Quality Systems Specialist III — Data Integrity & Compliance

RXinsider LTD.; Columbia (SC); Hybrid; USD 60,000 - 90,000; Full time

Job summary

RXinsider LTD. seeks a Quality Systems Scientific Specialist (Tier III) to ensure data integrity and regulatory compliance across APR reviews and QA document approvals.

You will analyze reports, identify discrepancies, and escalate issues while supporting continuous process improvements in a GMP environment. The role requires collaboration with QA teams, familiarity with FDA requirements, and strong technical writing and communication skills.

Qualifications

• Bachelor’s degree preferred with 1-2 years of pharmaceutical experience in Quality Systems or relevant area preferred.
• 1-3 years experience with MS Word, Excel, and PowerPoint preferred.
• 1-2 years project management and coordinator experience preferred.

Responsibilities

• Responsible for ensuring compliance with all State and Federal regulatory bodies as it pertains to the completion of Annual Product Reviews (APR) for all Nephron Pharmaceuticals Corporation (Nephron) and Nephron 503B Outsourcing Facility (503B) drug products.
• Responsible for performing Quality Assurance reviews of Microbiology and Chemistry documents for final Quality Approval. This includes review of method validation protocols and summary reports, Media Fills, environmental monitoring performances qualifications, drug supply chain security act, and other related documentation provided to the Quality Systems Scientific Team.
• Review and approval of protocols and summary reports for Process Development (PD) studies, stability studies, validation studies, and additional documentation as requested.
• Review and approve initiations and final reports of laboratory investigations for Chemistry and/ or Microbiology related events.
• Stay abreast of current FDA requirements and ensure compliance by familiarity with important department Standard Operating Procedures (SOPs) and routine observance of procedures being performed.
• Report any quality related issues to Quality Systems Scientific Manager or Quality Systems Director.
• Assist in other activities (as needed) for Quality Assurance Management.

Skills

Root Cause Analysis

Technical writing

Written and oral communication

Team player

Regulatory compliance awareness

Education

Bachelor's degree in science

1-2 years pharma quality systems

Tools

MS Word

Excel

PowerPoint

Job description

RXinsider LTD. seeks a Quality Systems Scientific Specialist (Tier III) to ensure data integrity and regulatory compliance across APR reviews and QA document approvals.

You will analyze reports, identify discrepancies, and escalate issues while supporting continuous process improvements in a GMP environment. The role requires collaboration with QA teams, familiarity with FDA requirements, and strong technical writing and communication skills.