Senior QA Lead - GMP, Batch Release & Compliance

Katalyst-Healthcares-; Durham (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

Creative Solutions Services, LLC is seeking an Operational Area Senior Quality Specialist to provide QA support across manufacturing, analytical labs, and materials management for external programs. You will review batch data, deviations, and QC release testing to support product disposition.

The role requires leading event investigations, CAPA, and applying risk-based decision making with GMP oversight. Strong communication and MS Office skills are essential, with familiarity in TrackWise/Veeva

Qualifications

• BS degree in a scientific or allied health field or equivalent experience.
• Experience providing QA support and oversight of GMP manufacturing.
• Experience leading event investigations and CAPA.
• Experience with TrackWise, Veeva, and Oracle systems.
• Knowledge of current industry trends and technologies.

Responsibilities

• Review batch records and approve quality tasks for externally manufactured products.
• Perform final review of batch and critical documentation for acceptability.
• Ensure required documentation is present prior to product release.
• Support day-to-day batch release processes.
• Assist audits and external inspections as needed.
• Communicate with internal/external partners and management.
• Maintain easily retrievable documentation files.
• Assist monthly/quarterly quality system data reviews.
• Escalate major findings to Quality management and monitor KPIs.

Skills

Strong communication

Critical thinking

Risk-based decisions

Microsoft Office

GxP QA experience

CAPA investigations

Event investigations

Root Cause Analysis

Aseptic processing

Quality metrics dashboards

GMP oversight

Education

Bachelor's degree in science

Tools

TrackWise

Veeva

Oracle

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.
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.