Senior QA Specialist, cGMP Compliance & Batch Release

Fagron Tech; Canton, Northern (MA, KY); Hybrid; USD 100,000 - 140,000; Full time

Job summary

Fagron US is seeking a Quality Assurance Senior Specialist to oversee cGMP manufacturing QA activities, documentation, and product disposition for compounded products.

You will perform Level 1–3 QA tasks, support batch records, change controls, and audits, and ensure ALCOA standards while maintaining training and compliance.

This role requires a college degree and 8–10 years in pharmaceutical quality, with proficiency in MS Office and MasterControl; analytics and collaboration are essential.

Qualifications

• College Degree and 8–10 years cGMP experience.
• Experience with quality systems and CAPA processes.
• Proficient with MS Office programs.
• Familiar with ALCOA documentation standards.

Responsibilities

• Execute Level 1–3 QA tasks including line clearances and label review.
• Issue and review batch records and manufacturing data.
• Review incoming materials and testing data for compliance.
• Dispositions of finished products and change controls.
• Support inspections and audits by providing documentation.

Skills

ALCOA familiarity

Attention to detail

Communication

Education

College Degree

Tools

MS Office (Word, Excel)

MasterControl

Quality Systems

Job description

Fagron US is seeking a Quality Assurance Senior Specialist to oversee cGMP manufacturing QA activities, documentation, and product disposition for compounded products.

You will perform Level 1–3 QA tasks, support batch records, change controls, and audits, and ensure ALCOA standards while maintaining training and compliance.

This role requires a college degree and 8–10 years in pharmaceutical quality, with proficiency in MS Office and MasterControl; analytics and collaboration are essential.