Quality Assurance Senior Specialist, Distribution (Contract) 28815

Vertex Pharmaceuticals•Boston, MA

About The Position

The Senior Specialist role involves working with the GDP Operational QA Management team to ensure that medicines are distributed in the USA in compliance with GDP and GMP requirements. The Quality Senior Specialist will manage the day-to-day Quality oversight of Third Party Logistics providers and provide support for key stakeholders within Vertex.

Requirements

Bachelor’s degree in a scientific or allied health field (or equivalent degree)
GDP work experience, or relevant comparable background.
Ability to work under moderate supervision
Ability to work and coordinate cross-functionally
Experience with and ability to use Microsoft Office and associated tools (Word, Excel, PowerPoint)
Demonstrated experience with handling compliance issues, resulting from deviations or product defects
Proactive approach and strong critical thinking skills
Must be able to work in a team environment within own team and inter-departmental teams
Excellent communication and interactive skills
Technical Writing
Good organizational and time management skills and able to demonstrate flexibility and adaptability.
Able to prioritize workload, decisive thinker, able to work within agreed timescales.
A high Level of attention to detail

Responsibilities

Support the oversight of Distribution Partners within the USA, including: Preparation and maintenance of Quality Agreements
Review of deviations, CAPA and changes
Maintaining KPIs
Analyze, resolve, or assist in solving compliance and customer issues.
Escalation of issues
Finish Goods Release at 3PL
Remain up to date in GDP and logistics developments and emerging regulations to guide the maintenance of the QMS
Working collaboratively with key internal stakeholders
Support Clinical QA Distribution
Maintain QMS within the Vertex Pharmaceuticals Incorporated.
Support recalls, mock recalls and any other on-market activity.
Serve as QA assessor/approver on Change Controls: resolve gaps, approve change plans, classifications, strategy for GDP/GMP actions.
Post inspection follow-up with responses and CAPAs (Continuous improvements)