Senior Quality Specialist

Katalyst CRO; Wilmington (DE); On-site; USD 92,000 - 125,000; Full time

Job summary

VCGT seeks an Operational Area Senior Quality Specialist to provide QA support 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 support product disposition.

The role requires experience overseeing GMP manufacturing operations, leading CAPA investigations, and utilizing TrackWise/Oracle/Veeva.

Qualifications

• Bachelor's degree in a scientific or allied health field.
• Experience providing QA support and oversight of GMP manufacturing operations.
• Experience leading event investigations, Root Cause Analysis and CAPA.
• Familiar with Oracle, TrackWise and Veeva systems.

Responsibilities

• Review batch records and provide approval for quality tasks for externally manufactured products.
• Perform final review of batch and critical systems documentation to determine acceptability.
• Ensure required documentation is present prior to product release.
• Support day-to-day management of the batch release process.
• Assist in quality audits and participate in corporate/external inspections as needed.
• Proactively communicate with internal and external partners and management.
• Maintain files for easy retrieval of documents.
• Assist with monthly/quarterly Quality System data review metrics and reporting.
• Escalate critical and major findings to Quality management and monitor KPIs.

Skills

Communication skills

Critical thinking

Risk-based decision making

MS Office

Cell/Gene Therapy QA

QA oversight GMP

CAPA investigations

Industry trends

Education

Bachelor's degree in science

Tools

Oracle

TrackWise

Veeva

Job description

Summary

The Operational Area Senior Quality Specialist will provide QA support of manufacturing operations, analytical laboratory operations and materials management for the external manufacturing programs at VCGT. This role will review batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems documentation as needed in support of product disposition.

Summary

The Operational Area Senior Quality Specialist will provide QA support of manufacturing operations, analytical laboratory operations and materials management for the external manufacturing programs at VCGT. This role will review batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems documentation as needed in support of product disposition.

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 standard operating procedures
• Ensures presence and acceptability of all required documentation prior to the release of the 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 such that documents are readily available and easily retrievable.
• Assists department with monthly/quarterly Quality System data review metrics and reporting
• Escalate critical and major finding to Quality management and monitor key performance indicators in collaboration with Quality Systems and other GXP Operational areas.
• Education and Experience:
• 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 successfully leading event investigations, Root Cause Analysis and CAPA
• Experience with network-based applications such as Oracle, TrackWise, Veeva
• Knowledge of current industry trends and ability to use the latest technologies.

Required Knowledge/Skills

• Strong communication and influencing skills.
• Critical Thinking / Problem Solving.
• Ability to evaluate quality matters and make decisions utilizing risk based approach.
• Proficiency in using Microsoft Office applications.
• Some experience with, Cell and/or Gene Therapy QA experience, working knowledge of aseptic processing, and quality metrics, dashboards, analysis and improvement programs.
• Some experience providing QA support and oversight of GMP manufacturing operation.
• Some experience successfully participating in event investigations, Root Cause Analysis and CAPA.
• Basic knowledge of current industry trends and has the ability to use the latest technologies.