Senior Quality Systems Specialist – GMP Packaging Analytics

Katalyst CRO; Laramie (WY); On-site; USD 70,000 - 100,000; Full time

Job summary

Vertex seeks a Quality Systems Senior Specialist to design and deliver metrics across GxP operations, providing actionable insights to quality leadership and prompt evaluation of trends and deviations. The role independently supports QA of packaging/ labelling validations, manufacturing operations, and new product launches at CMOs.

You will review validation documentation, batch data, deviations, change controls, and other quality systems records to support validation and product disposition,

Qualifications

• Bachelor's degree in a scientific, engineering, or allied health field and 3+ years of relevant work experience.
• 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.
• Able to navigate a fast-paced work environment.
• A desire to be part of a highly innovative company transforming lives.

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 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 retrievable.
• Assists department with monthly/quarterly Quality System metrics and reporting.

Skills

Attention to detail

Independent

Effective communicator

Education

Bachelor's degree in a scientific, engineering, or allied health field

Job description

Vertex seeks a Quality Systems Senior Specialist to design and deliver metrics across GxP operations, providing actionable insights to quality leadership and prompt evaluation of trends and deviations. The role independently supports QA of packaging/ labelling validations, manufacturing operations, and new product launches at CMOs.

You will review validation documentation, batch data, deviations, change controls, and other quality systems records to support validation and product disposition,