GMP Operational Quality Senior Specialist - Packaging/Labeling (Contract) 883

Vertex Pharmaceuticals LLC; Boston (MA); Sur place; USD 76 000 - 103 000; Plein temps

Résumé du poste

The Sr. Specialist GMP QA Operations at Vertex Pharmaceuticals LLC will work independently to oversee quality initiatives in GMP packaging/labeling, batch review and release, and external vendor oversight in a commercial drug environment.

Responsibilities include leading investigations, root cause analysis, CAPA, change controls, and continuous improvement efforts, while collaborating with cross-functional teams and ensuring regulatory compliance.

Qualifications

• Bachelor's degree in a scientific or allied health field is required.
• Experience in batch release, GMP environment, or equivalent is required.
• Experience supporting multiple projects and cross-functional teams is expected.

Responsabilités

• Master and executed batch record review and resolution of comments/issues.
• Archiving batch documents in electronic document system.
• Track data for metrics generation.
• Evaluate Investigations/OOS/Change Controls to support Disposition Status.
• Disposition decision and status change in Oracle.
• Provide quality oversight for root-cause analysis and product impact assessment.
• Support change control assessments, implementation and closure.
• Identify and facilitate continuous improvement efforts.
• Draft and revise Quality Agreements between CMOs/Suppliers and Vertex as needed.
• Represent Vertex Quality on cross-functional teams and drive CAPA actions.
• Support continuous improvement projects.

Connaissances

Batch release

GMP knowledge

Quality systems

Root Cause Analysis

CAPA

Cross-functional collaboration

Investigations

Change controls

Quality oversight

Problem solving

Formation

Bachelor's degree in scientific or allied health field

Outils

Oracle

Description du poste

Job Description

The Sr. Specialist GMP QA Operations works with a high degree of independence, while providing oversight of the development, implementation and maintenance of relevant quality initiatives in support of their function. The Senior Specialist completes work in a resourceful, self-sufficient manner and is able to design alternative approaches to achieve desired outcomes. They are adept at troubleshooting problems, coordinating and executing activities on multiple complex projects ensuring alignment with corporate goals and compliance with all regulatory requirements.

*** The ideal candidate will have ample experience in Quality, GMP Packaging/Labeling as well as batch review, release, CMO - external vendors in a commercial drug environment ***

Key Duties and Responsibilities

• Master and Executed Batch Record review and resolution of comments/issues
• Archiving of batch documents in electronic document system
• Track data for the purpose of metrics generation
• Evaluations of Investigations/ OOS/ Change Controls to support Disposition Status
• Disposition Decision and status change in Oracle
• Supports quality oversight for root-cause analysis and product impact assessment for investigations as a result of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified.
• Supports change control assessments, implementation and closure
• Identifies and facilitates continuous improvement efforts
• Supports drafting and revising Quality Agreements between CMOs/Suppliers and Vertex, as needed
• Helps represents Vertex Quality on cross-functional working teams, applying strong communication and collaboration skills.
• Support continuous improvement projects

Knowledge and 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
• Proficient in leading event investigations, Root Cause Analysis (RCA), and CAPA

Education and Experience

• Bachelor's degree in scientific or allied health field (or equivalent degree)
• Requires experience in batch release, GMP environment, or the equivalent combination of education and experience

Pay Range

$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

No C2C or Third-Party Vendors