Senior Quality Specialist
Katalyst Healthcares & Life SciencesLaramie, WY
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Overview
Remote
On-site
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.
- 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.
- 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.
- 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.
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FAQs About Senior Quality Specialist Jobs at Katalyst Healthcares & Life Sciences
What is the work location for this position at Katalyst Healthcares & Life Sciences?
This job at Katalyst Healthcares & Life Sciences is located in Laramie, WY, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Katalyst Healthcares & Life Sciences?
Employer has not shared pay details for this role.
What employment applies to this position at Katalyst Healthcares & Life Sciences?
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