Senior QA Specialist — GMP, Batch Release & CAPA

Katalyst CRO; Durham (NC); On-site; USD 110,000 - 140,000; Full time

Job summary

Katalyst CRO is seeking an Operational Area Senior Quality Specialist to support QA for manufacturing operations, analytical labs, and materials management for external programs. You will review batch data, deviations, in-process data, EM data, QC release testing, and other quality systems documentation to enable product disposition.

You will lead event investigations, CAPA, and risk-based decision making while aligning with corporate QA standards.

Qualifications

• Bachelor’s degree in a scientific or allied health field or the equivalent combination of education and experience.
• Experience providing QA support and oversight of GMP manufacturing operation.
• Experience leading event investigations, Root Cause Analysis and CAPA.
• Experience with Oracle, TrackWise, Veeva or similar systems.
• Knowledge of current industry trends and latest technologies.

Responsibilities

• Reviews executed batch records and provides customer approval for quality tasks for externally manufactured products.
• Performs final review of executed batch and/or critical systems documentation and determines acceptability by using SOPs.
• Ensures presence and acceptability of all required documentation prior to release of product and/or system.
• Support the day to day management of the batch release process.
• Assist the facility in preparation for quality audits and participate in corporate audits and external inspections as needed.
• Communicates proactively with internal and external partners and management.
• Maintains files so documents are readily available and retrievable.
• Assists department with monthly/quarterly Quality System data review metrics and reporting.
• Escalate critical and major findings to Quality management and monitor KPIs with Quality Systems and other GXP areas.

Skills

QA Oversight

GMP Manufacturing

CAPA Investigations

Root Cause Analysis

TrackWise

Veeva

Oracle

Communication

Problem Solving

MS Office

Education

Bachelor's degree in a scientific or allied health field

Tools

Oracle

TrackWise

Veeva

MS Office

Job description

Katalyst CRO is seeking an Operational Area Senior Quality Specialist to support QA for manufacturing operations, analytical labs, and materials management for external programs. You will review batch data, deviations, in-process data, EM data, QC release testing, and other quality systems documentation to enable product disposition.

You will lead event investigations, CAPA, and risk-based decision making while aligning with corporate QA standards.