Senior Quality Release Specialist - GMP & Batch Ownership

Katalyst-Healthcares-; Cambridge (MA); On-site; USD 110,000 - 150,000; Full time

Job summary

Creative Solutions Services, LLC seeks an Operational Area Senior Quality Specialist to provide QA support for manufacturing operations, analytical labs, and materials management for external manufacturing programs. You will review batch data, deviations, in-process data, EM data, QC release testing, and quality systems documentation for product disposition.

You will lead events investigations, ensure documentation readiness for release, and support audits and external inspections while

Qualifications

• Bachelor's degree in a scientific or allied health field.
• Experience providing QA support and oversight of GMP manufacturing operation.
• Experience leading event investigations, RCA and CAPA.

Responsibilities

• Reviews batch records and provides customer approval for QA tasks for externally manufactured products.
• Performs final review of batch and critical systems documentation and determines acceptability per SOPs.
• Ensures presence and acceptability of all required documentation prior to product/system release.
• Support the day-to-day management of the batch release process.
• Assist in preparation for quality audits and participate in corporate/external inspections.
• Communicates with internal and external partners and management.
• Maintains retrievable documentation files.
• Assists with monthly/quarterly Quality System data review metrics and reporting.
• Escalate findings to Quality management and monitor KPIs with Quality Systems.

Skills

QA oversight

GMP

Root Cause Analysis

CAPA

Microsoft Office

Communication

Problem Solving

Risk-based decisions

Event investigations

Quality metrics

Data dashboards

Aseptic processing

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.
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.