Operational Area Senior Quality Specialist (Contract) 671

Vertex Pharmaceuticals; Boston (MA); On-site; USD 84,000 - 90,000; Full time

Job summary

Vertex Pharmaceuticals seeks an Operational Area Senior Quality Specialist to provide QA support for manufacturing, analytical labs and materials management for external programs. You will review batch data and deviations to support product disposition and contribute to batch release processes.

Ideal candidates have GMP experience, strong problem solving and communication skills, and familiarity with TrackWise, Veeva and Oracle.

Qualifications

• Bachelor's degree in a scientific or allied health field.
• Experience providing QA support and oversight of GMP manufacturing operations.
• Experience leading event investigations, root cause analysis and CAPA.
• Experience with Oracle, TrackWise, and Veeva.
• Proficient in Microsoft Office applications.

Responsibilities

• Review executed batch records and provide approvals for quality tasks for externally manufactured products.
• Perform final review of executed batch and critical systems documentation to determine acceptability.
• Ensure presence and acceptability of all required documentation prior to release of product or system.
• Support day-to-day management of the batch release process.
• Assist facility for quality audits and participate in corporate audits and external inspections as needed.
• Communicate proactively with internal and external partners and management.
• Maintain files so documents are readily available and retrievable.
• Assist department with monthly/quarterly Quality System data review metrics and reporting.
• Escalate critical and major findings to Quality management and monitor KPIs with Quality Systems and other GXP areas.

Skills

Communication

Critical Thinking

Problem Solving

Risk-based thinking

MS Office

Education

Bachelor's degree in scientific field

Tools

Oracle

TrackWise

Veeva

Excel

Job description

Job Description

The Operational Area Senior Quality Specialist will provide QA supportofmanufacturing 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:

• Reviewsexecutedbatch 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 theday to daymanagement 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 utilizingrisk basedapproach

• Proficiency in using Microsoft Office applications

• Some experiencewith,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 withnetwork basedapplications such as Oracle,TrackWise, Veeva

• Basic knowledge of current industry trends andhas the ability touse the latest technologies

Pay Range

$61-$65/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

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