Quality Ops Specialist: Labeling & Artwork

Creative Solutions Services, LLC; Boston (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a Quality Systems Senior Specialist to design and deliver QA metrics across GxP operations. You will support packaging/labelling validations, manufacturing operations, and new product launches at CMOs, reviewing validation docs, batch data, deviations, and change controls.

Ideal candidates have a science/engineering background with 3+ years of QA experience, strong attention to detail, and the ability to communicate with stakeholders in a fast-paced

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 and ability to work independently in a fast-paced environment.
• Excellent communication skills and a drive to contribute to quality improvements.

Responsibilities

• Reviews validation documentation.
• Performs final review of executed batch records and resolves comments with the CMO.
• Reviews master batch records for validation and launch, ensuring changes are documented in the 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 processes.
• Communicates proactively with internal and external stakeholders and management.
• Maintains files for quick retrieval and supports monthly/quarterly QMS metrics reporting.

Skills

Attention to detail

Self-motivated

Independent worker

Effective communicator

Fast-paced environment

Education

Bachelor's degree in science/engineering/health

Tools

Veeva

Job description

Creative Solutions Services, LLC is seeking a Quality Systems Senior Specialist to design and deliver QA metrics across GxP operations. You will support packaging/labelling validations, manufacturing operations, and new product launches at CMOs, reviewing validation docs, batch data, deviations, and change controls.

Ideal candidates have a science/engineering background with 3+ years of QA experience, strong attention to detail, and the ability to communicate with stakeholders in a fast-paced