Senior Quality Specialist - Packaging/Labelling (Contract) 22494

The GMP QA Senior Specialist Packaging and Labeling – Validation & Launch works with a high degree of independence on multiple complex primary & secondary packaging validations, serialization validations and commercial manufacturing efforts for new product launches and line extensions in various regions. The Sr. Specialist provides support of the development, implementation, and maintenance of relevant quality initiatives in support of their function and completes work in a resourceful, self-sufficient manner. They can assess risk and design alternative approaches to achieve desired outcomes. The Sr. Specialist can troubleshoot problems, coordinate, and execute activities in alignment with corporate goals and compliance with all regulatory requirements.

This role is expected to work closely with business partners and stakeholders to ensure finished goods process validations are executed and commercial launch supply is available in global markets.

This position reports to the Senior Manager, GMP Operational Quality.

 The ideal candidate will have a background in QA, approving artwork digitally, documentation review and validation.

KEY RESPONSIBILITIES:

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

• Support Commercial Finished Goods product launch activities.
• Support Commercial Finished Goods process validation activities.
• Develops relationships with strategic external partners in support of Vertex’s expanding commercial portfolio and assist with ongoing relationships.
• Perform disposition activities for Finished Goods in support of Commercial Product for Validation and New product launch projects, including:
  • Review of Validation Master Plan, Process Validation Plan, Executed Protocol documentation.
  • Master and Executed Batch Record review and resolution of comments/issues.
  • Evaluations of Investigations/ OOS/ Change Controls to support Disposition Status
  • Status change in ERP System
  • Archiving of batch documents in electronic document system
  • Assist with Material Review Board activities, when necessary
• 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 compliance guidance to Commercial project teams.
  • Collaborative reviewer of internal procedures
  • Investigation guidance
  • Understand and support Business Partner needs.
• Serve as review/approver or owner of deviations.
• Support Commercial Labeling and Packaging manufacturing regarding new product introductions, geographic expansions and routine life-cycle management changes
  • Provide subject matter expertise on risk management, process control strategy, and continuous improvement opportunities (e.g. Lean Six Sigma, Kaizen, etc...).

• Commercial Artwork review and approval for new product introduction and routine life-cycle management changes.
  • Establish best practices for review and approval of global artwork / labeling assets to maintain quality and compliance
• Commercial Change Control
  • Serve as QA assessor/approver: resolve gaps, approve change plans, classifications, strategy for GMP release and disposition strategy.
• Provide Audit / Inspection Support

MINIMUM QUALIFICATIONS:

Bachelor’s degree in a scientific, engineering, or allied health field and 3+ years of relevant work experience, or comparable background.

PREFERRED QUALIFICATIONS:

• Small molecule primary & secondary packaging validation and product launch experience in the following markets: US, CA, EU/UK, AU, CH, IL, BR & RU, LATAM.
• Technical experience and engineering background
• Ability to thrive in a high throughput environment.
• Project Management / Continuous Improvement
  • Proficient in utilizing project management processes / tools to lead meetings, assist with project planning, and facilitate completion of tasks.
• Collaboration / Teamwork / Conflict Management
  • 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
• Flexibility/Adaptability
• Attention to detail.
• 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)
  • Veeva
  • MS Office