Aseptic Compounding Technician III - Early Shift

Fagron; Canton, Northern (MA, KY); Hybride; USD 39 000 - 52 000; Plein temps

Avantages offerts par ce poste

Competitive salary

Comprehensive benefits

Performance package

International pharmaceutical company

Résumé du poste

Fagron is hiring for a sterile compounding role in the US. You will perform and support aseptic compounding in ISO7 cleanrooms, ensuring compliance with cGMP, GDP, and SOPs while maintaining meticulous records.

The position requires gowning and aseptic processing experience, strong attention to detail, and ability to work independently in a regulated manufacturing environment. Competitive pay is offered.

Qualifications

• Previous experience working in a cGMP-regulated manufacturing environment.
• Strong understanding of cGMP and GDP requirements.
• Previous cleanroom gowning experience required.
• Previous aseptic processing or sterile compounding experience required.
• Ability to maintain required gowning and media fill qualifications.
• Strong attention to detail and commitment to quality.
• Ability to work independently while following established procedures and production schedules.
• Strong documentation and communication skills.
• Reliable attendance and punctuality.
• Ability to stand for extended periods, including up to 6 hours per shift.
• Ability to twist, bend, reach, and lift product materials as required during the shift.
• VLFH experience preferred.

Responsabilités

• Independently perform and support daily compounding activities, including batch staging, equipment preparation and cleaning, component preparation, and completion of batch records and logbooks.
• Independently assist with and compound assigned production batches in accordance with approved procedures and manufacturing schedules.
• Maintain a high level of aseptic technique and consistently follow gowning and cleanroom requirements.
• Meet Right First Time (RFT) expectations by minimizing errors and deviations and completing required corrections accurately and promptly.
• Maintain compliance with SOPs, cGMPs, GDP requirements, and established manufacturing procedures.
• Accurately document and reconcile components, materials, and quantities used throughout the compounding process.
• Maintain required gowning and media fill qualifications and demonstrate consistent compliance with cleanroom practices.
• Identify, troubleshoot, and appropriately elevate equipment, process, and compounding issues to management.
• Demonstrate strong documentation practices and maintain accurate, complete, and timely production records.
• Support continuous adherence to quality standards and contribute to a culture of safety, compliance, and operational excellence.
• Perform additional duties and responsibilities as assigned by management.

Connaissances

Aseptic processing

cGMP knowledge

GDP knowledge

Cleanroom gowning

Documentation

Independent work

Attention to detail

Communication skills

Reliability

Physical stamina

VLFH experience

Description du poste

Fagron is hiring for a sterile compounding role in the US. You will perform and support aseptic compounding in ISO7 cleanrooms, ensuring compliance with cGMP, GDP, and SOPs while maintaining meticulous records.

The position requires gowning and aseptic processing experience, strong attention to detail, and ability to work independently in a regulated manufacturing environment. Competitive pay is offered.