Compounding Technician II (Mon-Fri 5:30a-2p)

Fagron•Canton, MA

About The Position

The Sterile Compounding Technician II performs sterile compounding and pharmaceutical manufacturing in accordance with approved Master Batch Records (MBRs), Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMP), and applicable regulatory requirements. The position requires proficiency in aseptic techniques, cleanroom operations, batch documentation, and equipment handling. The technician independently performs assigned operator and assistant duties while maintaining product quality, safety, and compliance standards.

Requirements

High school diploma or equivalent.
Previous experience in sterile compounding, aseptic processing, pharmaceutical manufacturing, or a regulated cleanroom environment.
Working knowledge of aseptic techniques, contamination prevention, and cleanroom practices.
Ability to follow detailed manufacturing instructions, SOPs, and batch records.
Strong attention to detail, organizational skills, and commitment to quality and safety.
Ability to perform basic manufacturing calculations and accurately document production activities.
Ability to work independently within established procedures and escalate quality concerns appropriately.

Nice To Haves

Experience working in an FDA-regulated pharmaceutical manufacturing or 503B outsourcing facility.
Familiarity with cGMP, Good Documentation Practices (GDP), and pharmaceutical batch records.
Experience operating sterile manufacturing equipment and performing aseptic manipulations.

Responsibilities

Perform sterile compounding and manufacturing activities in accordance with approved MBRs, SOPs, and cGMP requirements.
Independently execute assigned operator and assistant duties, including routine and moderately complex production activities.
Prepare, measure, weigh, transfer, and handle materials used in sterile pharmaceutical manufacturing.
Support preparation and filling of sterile solutions, syringes, vials, infusion bags, and other approved dosage forms.
Maintain proper aseptic technique, gowning qualifications, and contamination-control practices in classified cleanroom environments.
Accurately complete batch production records, equipment logs, and material reconciliation documentation in accordance with Good Documentation Practices (GDP).
Perform cleaning, disinfection, equipment setup, and routine operational checks according to established procedures.
Verify material identification, lot numbers, expiration dates, and equipment readiness before use.
Identify and promptly report deviations, equipment malfunctions, contamination concerns, and potential product quality issues.
Support production efficiency, quality initiatives, inspections, and continuous improvement activities.
Complete required training, aseptic qualifications, media fills, and competency assessments.