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.
Key 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.
Additional Notes For Suppliers: - FG + Artwork referenced would be an excellent 'green flag'.
- FG Packaging typically would require some level of Artwork Management.
- If we are consistently looking for those qualifications we may find some relevant candidates.
- It will also be a plus is the person has experience investigating deviations related to artwork management and running in Veeva or a similar system and experience in continuous improvement processes
