Quality Ops: Labeling, Artwork & Packaging Validation

Katalyst CRO; Boston (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

Katalyst CRO Boston is seeking a Quality Systems Senior Specialist to design and deliver metrics across GxP operations. The role provides QA support for packaging/labeling validations, manufacturing operations, and new product launches at CMOs, ensuring timely product disposition.

You will review validation docs, batch records, deviations, change controls, and QA documentation, collaborate with quality leadership, and contribute to monthly metrics.

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 (packaging validation) preferred.
• Strong attention to detail.
• Self-motivated, independent, organized, and an effective communicator.
• Able to thrive in a fast-paced environment.
• Desire to contribute to transformative therapies.

Responsibilities

• Reviews validation documentation.
• Performs final review of executed batch records, resolves comments with CMO.
• Reviews master batch records for validation and launch, ensuring changes documented in Vertex QMS.
• Ensures presence and acceptability of required documentation prior to batch release.
• Reviews and approves investigations, CAPAs, and change controls for external programs.
• Supports day-to-day management of lot disposition processes.
• Communicates with internal and external stakeholders and management.
• Maintains files for easy retrieval; supports monthly/quarterly QA metrics.

Skills

Quality systems

GxP

QA documentation

Attention to detail

Communication

Education

Bachelor's degree in science/engineering/health

Tools

Vertex QMS

Veeva or similar system

Job description

Katalyst CRO Boston is seeking a Quality Systems Senior Specialist to design and deliver metrics across GxP operations. The role provides QA support for packaging/labeling validations, manufacturing operations, and new product launches at CMOs, ensuring timely product disposition.

You will review validation docs, batch records, deviations, change controls, and QA documentation, collaborate with quality leadership, and contribute to monthly metrics.