Bachelor's degree in a scientific, engineering, or health field and 3+ years of relevant experience
Experience in Finished Goods/Packaging/Labelling preferred
Proven ability in Commercial Validation, notably packaging validation
Strong attention to detail and organizational skills
Self-motivated with effective communication abilities
Capable of thriving in fast-paced environments
Desire to contribute to a company focused on innovative treatments for serious diseases
Responsibilities
Review validation documentation for compliance and accuracy
Perform final reviews of executed batch records and reconcile with CMOs
Verify documentation changes in master batch records within QMS
Ensure all required documentation is present before batch release
Review and approve CAPAs, investigations, and change controls for external programs
Manage lot disposition process effectively as needed
Proactively communicate with stakeholders and management about quality issues
Assist in generating monthly/quarterly Quality System metrics and reporting
Benefits
Opportunity to work with innovative solutions in healthcare
Engage in a collaborative environment with high independence
Participate in impactful projects that influence product quality and patient outcomes
Become part of a mission-driven organization dedicated to transforming lives
Access to professional development and career growth opportunities
Full Job Description
General Position Summary:
The Quality Systems Senior Specialist supports design and delivery of impactful metrics and analyses across GxP operations. The incumbent plays a vital role in delivering actionable insights to quality leadership teams that support demonstration of appropriate quality oversight and prompt evaluation of trends and deviations from expected results
The Operational Area Senior Quality Specialist works with a high degree of independence to provide QA support of packaging/labelling validations (primary & secondary packaging as well as serialization), manufacturing operations, and new product launches at external contract manufacturing organizations (CMOs). This role will review validation documentation, batch data, deviations, change controls, and other quality systems documentation in support of validation and product disposition.
Responsibilities:
Reviews validation documentation.
Performs final review of executed batch records, resolves comments with CMO.
Reviews master batch records for validation and launch, verifying that all changes are appropriately documented in Vertex's QMS.
Ensures presence and acceptability of all required documentation prior to batch release.
Reviews and approves investigations, CAPAs, and change controls for external programs.
Support day to day management of lot disposition process as needed.
Communicates proactively with internal and external stakeholders and management.
Maintains files such that documents are readily available and easily retrievable.
ssists department with monthly/quarterly Quality System metrics and reporting.
Education And Experience:
Bachelor's degree in a scientific, engineering, or allied health field and 3+ years of relevant work experience, or comparable background.
Experience with Finished Goods/Packaging/Labelling preferred
Experience with Commercial Validation (especially packaging validation) preferred.
Strong attention to detail.
Self-motivated, independent, organized, and an effective communicator.
Has the ability to navigate a fast-paced work environment.
desire to be part of a highly innovative company aimed at transforming the lives of people with serious diseases, their families and society.
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.
Technical experience and engineering background
Experience leading complex projects/teams and continuous improvement initiatives within stated objectives and timelines; effectively applies project management processes / tools to lead meetings, assist with project planning, and facilitate completion of tasks.
