GMP Operational Quality Sr Specialist (Batch Record Review) (Contract) 649-2

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

Job summary

Vertex Pharmaceuticals in Boston is seeking an Operational Area Senior Quality Specialist to provide QA support for manufacturing, analytical labs, and materials management within external programs. You will review batch data, deviations, and QC release testing to aid product disposition while maintaining cGMP compliance.

This is a Monday–Friday fully onsite role where you will lead investigations, CAPA actions, and drive continuous improvement in quality systems and batch release processes.

Qualifications

• Bachelor's degree in a scientific or allied health field or the equivalent combination of education and experience.
• Typically requires 2 years of experience, or the equivalent combination of education and experience.
• Experience providing QA support and oversight of GMP manufacturing operation.

Responsibilities

• Reviews executed batch records and provide 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 product release.
• Support day-to-day management of the batch release process.
• Assist the facility in preparation for quality audits and participate in external inspections.
• Maintains files so documents are readily available and retrievable.
• Assist department with Quality System data review metrics and reporting.
• Escalate critical findings to Quality management and monitor KPIs.

Skills

cGMP compliance

QA oversight

Root Cause Analysis

Cross-functional communication

Electronic documentation systems

Education

Bachelor's degree in science or related field

Tools

QDoccs

Trackwise

Veeva

Job description

Job Description

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. 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 as shop floor quality specialist while ensuring compliance with cGMPs policies and procedures. The Quality Sr. 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 Monday to Friday fully onsite role

Key Duties and Responsibilities:

• Reviews executed batch records and provide 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
• 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
• 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 a scientific or allied health field or the equivalent combination of education and experience

• Typically requires 2 years of experience, or the equivalent combination of education and experience

• Experience providing QA support and oversight of GMP manufacturing operation

Pay Range

$65-$70/hr