Senior QA Specialist: cGMP Compliance Lead

Fagron; Canton (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

Fagron US seeks a Quality Assurance Senior Specialist to lead cGMP QA activities across manufacturing, packaging and distribution of compounded products. This role ensures ALCOA-compliant documentation and effective release processes.

The ideal candidate will demonstrate mastery across Level 1–3 QA tasks, batch records, change controls, CAPA and problem-solving within a fast-paced pharmaceutical environment. Excellent communication and attention to detail are essential.

Qualifications

• College Degree and 8–10 years cGMP experience in a pharmaceutical manufacturing company or equivalent.
• Experience with quality systems, aseptic technique, cGMP document review, quality investigations, CAPA, Change Control and MasterControl preferred.
• Proficient in MS Office programs, including Word and Excel.
• Ability to process information rapidly from multiple sources and communication channels.

Responsibilities

• Perform Level 1: manufacturing/packaging clearances, label review, label reconciliation, EMS data review, logbook review.
• Perform Level 2: batch record issuance/review, incoming material review, form/logbook issuance, testing data review, event reports and CAPA.
• Perform Level 3: disposition/release of materials and finished product, document control, change controls, moderate risk deviations.
• Support QA projects of low to moderate complexity and assist with batch records and systems for compounding processes.
• Ensure day-to-day compliance with all requirements for compounded products and related systems.
• Assist with problem identification/resolution for QA issues and participate in inspections/audits.
• Contribute to metrics on quality system effectiveness and ensure cGMP documentation meets ALCOA standards.

Skills

Strong communication skills

Detail-oriented

Adaptability

Problem solving

Education

Bachelor's degree or equivalent

Tools

MS Office (Word, Excel)

MasterControl

Quality systems

Job description

Fagron US seeks a Quality Assurance Senior Specialist to lead cGMP QA activities across manufacturing, packaging and distribution of compounded products. This role ensures ALCOA-compliant documentation and effective release processes.

The ideal candidate will demonstrate mastery across Level 1–3 QA tasks, batch records, change controls, CAPA and problem-solving within a fast-paced pharmaceutical environment. Excellent communication and attention to detail are essential.