Senior QA Lead: GMP Compliance, Batch Release & Audits

Katalyst-Healthcares-; Boston (MA); Vor Ort; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

Creative Solutions Services, LLC is seeking an Operational Area Senior Quality Specialist to provide QA support of manufacturing operations, analytical laboratory operations and materials management for external manufacturing programs at VCGT.

You 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.

Qualifikationen

• Bachelor's degree in a scientific field or equivalent combination of education and experience.
• Experience providing QA support and oversight of GMP manufacturing operations.
• Experience leading event investigations, root cause analysis and CAPA.

Aufgaben

• 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.
• Ensures presence and acceptability of all required documentation prior to 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.

Kenntnisse

Communication

Critical Thinking

Risk Analysis

MS Office

GMP QA

CAPA

Ausbildung

Bachelor's degree in science

Tools

Oracle

TrackWise

Veeva

Jobbeschreibung

General 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.
Key Duties and 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.