Operational Area Quality Senior Specialist (Contract)

Vertex Pharmaceuticals LLC; Boston (MA); Hybrid; USD 84,000 - 95,000; Full time

Job summary

Vertex Pharmaceuticals LLC in Boston, MA is seeking a GMP Operational Quality Senior Specialist to support QA and regulatory compliance, focusing on APQR delivery and quarterly product quality trending. The role reports to the Director of Quality Systems and involves cross-functional collaboration in a hybrid, 3 days in-office schedule.

The position requires a Bachelor's degree in a scientific field, experience with deviations/RCA/CAPA, and familiarity with Veeva and cgMP practices.

Qualifications

• Bachelor's degree in a scientific or allied health field or the equivalent combination of education and experience.
• Experience with event investigations (deviations), Root Cause Analysis (RCA), and CAPA.
• Expanded knowledge of cGMPs in a pharmaceutical setting.
• Experience supporting multiple projects/teams within stated objectives and timelines.
• Good communication skills (written and verbal) and the ability to exchange potentially complex information.

Responsibilities

• Delivery of Annual Product Quality Reviews (APQRs) for all commercial products.
• Coordinates with SMEs to develop the scope and content of APQRs.
• Ensures appropriate CAPA actions are identified and tracked.
• Ensures completed APQRs are approved and archived.
• Assist with quarterly product quality trending for commercial products.
• Assist with preparation of Quality Management Review materials.
• Identify and facilitate continuous improvement efforts.
• Represent Vertex Quality on cross-functional teams and collaborate effectively.
• Support continuous improvement projects.

Skills

CAPA processes

Cross-functional collaboration

Root Cause Analysis

Regulatory compliance

Excellent communication

Education

Bachelor's degree

Tools

Veeva

Quality Management System

Job description

Job Description

The GMP Operational Quality Senior Specialist supports the principles and application of quality assurance and regulatory compliance. The incumbent supports or executes a wide range of straightforward activities and supports new/existing project initiatives. This individual is primarily responsible for coordinating the delivery of Annual Product Quality Review (APQR) and Quarterly Product Quality trending.

This position reports directly to the Director of Quality Systems.

Key Responsibilities:

The responsibilities of this position may include, but are not limited to, the following:

• Delivery of Annual Product Quality Reviews (APQRs) for all commercial products.
• Coordinates with SMEs to develop the scope and author content of APQRs.
• Ensures appropriate CAPA actions are identified.
• Ensures completed reports are approved and archived.
• Assist with executing and developing quarterly product quality trending for commercial products manufactured at Vertex and Contract Manufacturing Organizations.
• Assist with preparation of Quality Management Review materials.
• Identifies and facilitates continuous improvement efforts.
• Helps represent Vertex Quality on cross-functional working teams, applying strong communication and collaboration skills.
• Support continuous improvement projects.

Required education level:

• Bachelor's degree in a scientific or allied health field or the equivalent combination of education and experience.

Required experience:

• Experience with event investigations (deviations), Root Cause Analysis (RCA), and CAPA.
• Experience with network-based applications such as Veeva.
• Knowledge of current industry trends and ability to use the latest technologies.

Required knowledge/skills:

• Experience supporting multiple projects/teams within stated objectives and timelines.
• Experience supporting cross-functional team members and collaborate effectively.
• Good communication skills (written and verbal) and the ability to exchange potentially complex information.
• Able to integrates activities with other groups, departments and project teams as needed.
• Demonstrated ability to support evaluation of quality matters and solve straightforward problems using technical experience and judgement based on precedent.
• Ability to work in a fast-paced environment and meet quality, accuracy, and timeliness objectives.
• Expanded conceptual knowledge of cGMP's in a pharmaceutical setting.

Contract Length: 12 months with the chance to extend.

Pay Range

$61/hr. - $69/hr.

Shift/Hours

Monday-Friday, hybrid role: three days in the office, two days at home.

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