GMP Operational Quality Sr. Specialist (QA on the floor) (Contract) 649-1

Vertex Pharmaceuticals LLC; Boston (MA); On-site; USD 90,000 - 96,000; Full time

Job summary

Vertex Pharmaceuticals is seeking a Quality Shop Floor Specialist to oversee floor quality for autologous cell and gene therapy production in a cGMP cleanroom. You will support batch records review, disposition, and ensure compliance with policy, procedures, and regulations.

The role requires strong collaboration with cross-functional teams, root-cause analysis, CAPA actions, data collection, and training. GMP practices and experience with electronic QA systems are preferred.

Qualifications

• Bachelor's degree in scientific or allied health field.
• Solid understanding of cGMPs in pharmaceutical setting.
• Experience leading projects or teams to deadlines.
• Strong written and verbal communication for cross-functional teams.

Responsibilities

• Support manufacturing activities for cGMP compliance and guide QA issues.
• Review batch records and perform product disposition.
• Collaborate with partners to resolve quality issues and implement compliant solutions.
• Lead root-cause analysis and CAPA actions for deviations, OOS, OOT.
• Train employees and support continuous improvement activities.

Skills

cGMPs knowledge

Project leadership

Cross-functional communication

Workload management

Written and verbal communication

Team player

Root Cause Analysis

CAPA experience

Education

Bachelor's degree in science or allied health

Tools

QDoccs

Trackwise

Veeva

Job description

Job Description

The Quality Shop Floor Specialist is responsible for the floor quality oversight of the production of autologous cell and gene therapy product in a controlled cGMP cleanroom environment. This position is responsible for quality and maintaining the highest standards in compliance per policy, procedures, and regulations. The role will also be responsible for supporting batch records review and disposition while ensuring compliance with cGMPs policies and procedures. The Quality Specialist coordinates or executes activities on a wide range of projects and plays a role in the design and execution of new projects.

This is a Sunday to Wednesday, first shift (7:00 AM to 5:30 PM EST) role.

Key Duties and Responsibilities:

• Support manufacturing activities for cGMP compliance and collaborate with site personnel to provide guidance and determine immediate path forward for manufacturing quality issues.
• Support shop floor check and audit trail review.
• Collaborate with business partners to resolve quality issues to ensure compliant solutions
• Support root-cause analysis and product impact assessment for investigations as a result of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified
• Collect data and report on metrics
• Represent Vertex Quality on cross functional working teams, applying strong communication and collaboration skills.
• Support continuous improvement projects
• Author SOP's to support commercial quality functions.
• Assist with regulatory agency inspections
• Identify and support continuous improvement efforts
• Train employees and provide insights and education on processes and procedures.
• Perform activities associated with product disposition (e.g., batch document review, source data review etc.)
• Gown into cleanrooms and controlled environments

Knowledge and Skills:

• Good understanding of both the conceptual and practical application of cGMPs in a pharmaceutical setting
• Proven experience leading a variety of straightforward projects/teams within stated objectives and timelines.
• Ability to communicate effectively with cross functional team members, exchanging complex information and influencing/guiding others to understand a stated viewpoint
• Ability manage own workload to achieve goals and seek opportunities to share information and help others understand technical processes
• Strong communication skills (written and verbal) with the ability to communicate to a variety of audiences.
• Able to integrates activities with other groups, departments and project teams as needed.
• Demonstrated ability to evaluate quality matters and solve problems leveraging technical experience and advanced judgement to select appropriate solutions
• Excellent team player and collaborator
• Highly proficient in leading event investigations, Root Cause Analysis (RCA), and CAPA
• Experience with electronic document management systems (e.g., QDoccs, Trackwise, Veeva)

Education and Experience:

• Bachelor's degree in scientific or allied health field (or equivalent degree)

Pay Range

$65-$70/hr

Requisition Disclaimer

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals ("Vertex"). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements

No C2C or Third-Party Vendors