Operational Quality Senior Specialist (Contract) 28773

Atrium Works • Boston, MA

3d • $55 - $65

About The Position

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 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 patterns 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 findings to Quality management and monitor key performance indicators in collaboration with Quality Systems and other GxP operational areas MINIMUM QUALIFICATIONS: 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 Some experience with network-based applications such as Oracle, TrackWise, Veeva Basic knowledge of current industry trends and has the ability to use the latest technologies

Requirements

• 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
• 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

Nice To Haves

• 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
• Some experience with network-based applications such as Oracle, TrackWise, Veeva
• Basic knowledge of current industry trends and has the ability to use the latest technologies

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 patterns 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 findings to Quality management and monitor key performance indicators in collaboration with Quality Systems and other GxP operational areas

What This Job Offers

• Career Level: Mid Level