Senior Quality Specialist – Finished Goods & Packaging

Creative Solutions Services, LLC

Boston (MA)

On-site

USD 95,000 - 130,000

Full time

7 days ago

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Job summary

Creative Solutions Services, LLC seeks a Quality Systems Senior Specialist to support metrics and analyses across GxP operations. You will help deliver actionable insights to quality leadership and ensure proper oversight of deviations and trends in packaging, labeling, and validation activities at CMOs.

You will review validation docs, batch data, deviations, change controls, and related quality systems to support validation and product disposition.

Qualifications

Bachelor's degree in a scientific, engineering, or allied health field with 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 accuracy.
Self-motivated, independent, organized, and an effective communicator.
Ability to navigate a fast-paced work environment.

Responsibilities

Reviews validation documentation.
Performs final review of executed batch records and resolves comments with CMO.
Reviews master batch records for validation and launch, ensuring changes are documented in QMS.
Ensures presence and acceptability of all 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 and communicates with stakeholders.