Quality Control Technician

Job Description

Job Description

Job Summary :

The job of the Quality Control Technician is to ensure compliance with cGMP requirements and company procedures while providing support to the QC team and throughout the QA and Operations departments. Additionally, this role is responsible for coordinating QC sample preparation and external laboratory shipments in relation to Environmental Monitoring activities and other required sampling. This role will work closely with the Production team and report quality data to department management, as needed.

Duties / Responsibilities :

• Maintain retention materials and disposal when required.
• Assist with review and release of raw materials, API, excipients, and sterile supplies.
• Coordination of Biohazard waste destruction.
• Perform sampling and inspection of in-process and finished products.
• Assists with Environmental Monitoring and microbiological sample evaluation activities.
• Coordination of submitting samples for testing with third party vendors on their respective web portals or paper submissions.
• Logbook and controlled document generation.
• Assist with investigations and develop and implement corrective and preventive actions geared toward continuous process improvements.
• Review GMP documents including production environmental monitoring forms, room and equipment logs, etc.
• Support quality management system activities including document control and training program management.
• Other duties and tasks, as assigned.

Required Skills / Abilities :

Education and Experience :

1-3 Years as a Quality Control Technician

Pharmaceutical, Medical Device, or biotechnology industry experience, preferably in support of manufacturing.

Associate degree in the sciences or equivalent experience preferred.

Physical Requirements :

Ability to work in a clean room setting

Prolonged periods of sitting at a desk and working on a computer.

Must be able to lift up to 15 pounds at times.