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.
- Assists 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.
- A 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
Must Submit with the following:
- PHOTO ID.
- Month and day of birth.
- Valid U.S. permanent address.
- (2-3) references from past managers with their "Company Emails ".
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 systemand experience in continuous improvement processess.