Senior Quality Specialist GMP Batch Release & QA

Katalyst-Healthcares-; Wilmington (DE); On-site; USD 85,000 - 115,000; Full time

Job summary

Creative Solutions Services, LLC in Wilmington, DE seeks an Operational Area Senior Quality Specialist to provide QA support for GMP manufacturing, analytical labs, and external programs. You will review batch data, deviations, and release documentation to support product disposition.

Responsibilities include batch record reviews, final documentation checks, release readiness, audits support, and data trending.

Qualifications

• Bachelor's degree in a scientific or allied health field or equivalent experience.
• Experience providing QA support and oversight of GMP manufacturing operation.
• Experience leading event investigations, RCA and CAPA.
• Experience with Oracle, TrackWise and Veeva systems.
• Knowledge of current industry trends and ability to use latest technologies.

Responsibilities

• Reviews executed batch records and grants quality task approvals for external products.
• Performs final review of batch and critical systems documentation for acceptability.
• Ensures documentation readiness prior to product/system release.
• Supports day-to-day batch release process management.
• Assists in quality audits and participates in external inspections.
• Communicates with internal and external partners and management.
• Maintains retrievable files and supports monthly/quarterly quality data reviews.
• Escalates major findings to Quality management and tracks KPIs.

Skills

QA oversight

GMP manufacturing

Root Cause Analysis

CAPA

Communication skills

Problem solving

Risk-based decisions

MS Office

Education

Bachelor's degree in a scientific or allied health field

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.
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.