Compounding Technician II – Aseptic Manufacturing

Fagron Tech; Canton, Northern (OH, KY); Hybride; USD 42 000 - 62 000; Plein temps

Avantages offerts par ce poste

Competitive salary

Comprehensive benefits

Performance package

Résumé du poste

Fagron US in Canton, OH is seeking a Sterile Compound Technician to perform and support sterile compounding in classified cleanroom areas, following cGMPs, SOPs, and aseptic practices in an ISO 7 environment.

The role requires attention to detail, the ability to work with limited supervision, and the discipline to maintain quality records, gowning and media fill qualifications, and strong teamwork.

Qualifications

• Previous manufacturing or related experience preferred.
• Working understanding of cGMP and GDP requirements in a manufacturing environment preferred.
• Previous gowning or cleanroom experience preferred.
• Ability to successfully complete and maintain required gowning and media fill qualifications.
• Strong attention to detail with the ability to multitask and prioritize work effectively.
• Quality-minded with a strong focus on accuracy and accountability.
• Reliable attendance and punctuality.
• Ability to follow established procedures and perform assigned compounding activities with limited supervision.
• Ability to communicate effectively with team members and management.
• 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.

Responsabilités

• Support daily compounding activities, including staging batches, equipment cleaning and set-up, and completion of batch records and logbooks.
• Independently perform assigned compounding activities in accordance with approved procedures and production requirements.
• Meet Right First Time (RFT) expectations by minimizing errors and deviations and completing required corrections accurately and promptly.
• Maintain adherence to SOPs, cGMPs, GDP requirements, and the manufacturing schedule.
• Assist with inventory control by accurately documenting components and materials used during production.
• Successfully complete and maintain required gowning and media fill qualifications.
• Maintain proper aseptic technique and follow established cleanroom procedures.
• Demonstrate the ability to prioritize and manage multiple production activities while maintaining quality and accuracy.
• Recognize and communicate process, equipment, or documentation concerns to supervisors or experienced team members.
• Work effectively both independently and as part of a team to meet production requirements.
• Demonstrate initiative by asking questions, seeking assistance when needed, and supporting team members.
• Perform additional duties and responsibilities as assigned by management.

Connaissances

Sterile compounding

Attention to detail

Ability to multitask

Independent work

Punctuality

Description du poste

Fagron US in Canton, OH is seeking a Sterile Compound Technician to perform and support sterile compounding in classified cleanroom areas, following cGMPs, SOPs, and aseptic practices in an ISO 7 environment.

The role requires attention to detail, the ability to work with limited supervision, and the discipline to maintain quality records, gowning and media fill qualifications, and strong teamwork.