Quality Operations Specialist � Labeling & Artwork

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

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

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.