Quality Senior Specialist, Finished Goods (Contract) 23308 - Vertex Pharmaceuticals

The Sr. Specialist 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 Sr. 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.

*** this ideal candidate will have ample experience with Batch Records adn Release Activities ***

Key Responsibilities:

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

• Perform disposition activities for Finished Goods in support of Clinical/Commercial Product, including:
  • Master and Executed Batch Record review and resolution of comments/issues
  • Evaluations of Investigations/ OOS/ Change Controls to support Disposition Status
  • Certificate of Analysis approval
  • Status change in Oracle
  • Archiving of batch documents in electronic document system, QDoCCS
  • Assist with Material Review Board activities, when necessary
• Lead quality oversight of artwork/label review, approval, & implementation
• Provides quality guidance 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
• Provide quality support for planning of product launches and tracking of new artworks
• Assist in packaging validation activities as needed
• Develops relationships with strategic external partners in support of Vertex’s expanding commercial portfolio and assist with ongoing relationships. 
• QP Relationship and Release
  • Facilitate QP Release of finished goods
  • Assist with QP Declaration requests
  • Incorporate QP expectations into quality systems
• Provide compliance guidance to Commercial project teams
  • Collaborative reviewer of internal procedures
  • Investigation guidance
  • Understand and support Business Partner needs
• Establishment of Quality Processes/Process Ownership – Packaging /Labeling and QP Release of Finished Goods
  • Serve as review/approver or owner of deviations
  • Monitors and trends events and identifies/proposes corrective actions
  • May serve as CAPA owner
  • Identifies risks and communicates gaps to management
  • Assists with the generation of process related metrics/monitors for efficiency
• Commercial Change Control
  • Serve as QA assessor/approver: resolve gaps, approve change plans, classifications, strategy for GMP release and disposition strategy
• Support deployment of the Quality Management System as GMP Representative:
  • Conduct ongoing monitoring of regulations and participate in update of Quality Systems Policy statements
  • Coordinate, Facilitate and Follow-up for Quality Leadership Team
  • May participate on process improvement initiatives
  • Review Risk Profile and Performance updates for presentation to Quality Leadership Teams as needed

Minimum qualifications:

Master’s degree and 0-3 years of relevant work experience, or Bachelor’s degree in a scientific or allied health field and 5-8 years of relevant work experience, or comparable background.

Preferred Qualifications:

• Strong leadership skills with the ability to thrive in a high throughput environment

• Project Management / Continuous Improvement

• Ability to lead and manage projects/teams within corporate objectives and project timelines

• Proficient in utilizing project management processes / tools to lead meetings, assist with project planning, and facilitate completion of tasks
  • Demonstrated ability to work independently to provide QA support for large, multifaceted projects

• Collaboration / Teamwork / Conflict Management
  • Ability to independently lead cross-functional teams and represent the Quality unit
  • Ability to understand and translate business needs
  • Represents Vertex Commercial Quality Assurance on cross functional working teams and is recognized for strong communication and influencing skills
• Critical Thinking / Problem Solving
  • Ability to evaluate quality matters and make decisions utilizing risk based approach
• Flexibility/Adaptability
• Attention to detail
• Knowledge in the following areas:
  • Expert knowledge of global GMP requirements governing oral drug products and knowledge of oral drug product manufacturing practices
  • GMP/GDP regulations and application to Manufacturing and Testing risk management principles
  • Root Cause Analysis tools/methodology
  • Knowledge of packaging and labeling process  and artwork requirements
  • Audit process
• Broad GMP Knowledge and understanding across lifecycle of the product
• Sense of urgency- ability to act quickly/escalation process/transparency
• Ability to:
  • Drive results on time every time
  • Maintain composure under pressure
  • Take ownership and accountability for shared information
  • Understand and translate customer needs
• Knowledge of applications:
  • OPM (Oracle)
  • QDoCCs
  • Trackwise
  • MS Office

$55-$65

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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