QA Operations Lead - cGMP & Compliance

Fagron; Canton (MA); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

401(k) with company match

Medical, vision, dental insurance

Health Savings Account (HSA)

Paid time off

Job summary

Fagron is seeking a Quality Assurance Supervisor to lead the QA team in supporting cGMP manufacturing, documentation, and product disposition. The role ensures proper controls are maintained during compounding, packaging and warehousing, with oversight of site quality systems to meet compliance.

The supervisor will coach QA staff, manage batch records, change controls and investigations, and drive continuous improvement in quality metrics.

Qualifications

• Bachelor's degree and 10+ years of cGMP pharmaceutical experience
• Experience with quality systems, CAPA, Change Control and document review
• Proficient in MS Office programs including Word and Excel

Responsibilities

• Lead a QA team with 3–7 direct reports (QA Generalist/Specialist/Officer)
• Coach and develop staff across Level 1–3 QA tasks
• Approve Batch Records; review testing data and events
• Review and approve Change Controls and CAPA investigations
• Ensure cGMP documentation meets ALCOA standards
• Lead or assist with internal and external inspections and audits
• Track KPIs and manage performance of direct reports
• Provide QA guidance for manufacturing functions and compliance
• Support manufacturing quality systems for compounding processes

Skills

Quality systems

Aseptic technique

cGMP document review

Quality investigations

CAPA

Change Control

Decision making

Education

Bachelor's degree

Tools

MS Office

MasterControl

Job description

Fagron is seeking a Quality Assurance Supervisor to lead the QA team in supporting cGMP manufacturing, documentation, and product disposition. The role ensures proper controls are maintained during compounding, packaging and warehousing, with oversight of site quality systems to meet compliance.

The supervisor will coach QA staff, manage batch records, change controls and investigations, and drive continuous improvement in quality metrics.