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JOB DESCRIPTION

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The Quality Control Technician (QCT) will be a member of the Stability Biologics Quality Dept. to perform testing, monitoring and evaluation of the facility, processes and products.  The QCT will be responsible for quality control metrics, conducting QC inspections, perform testing, transfer products and maintaining the QC Lab and Quarantine areas. The QC Technician will also be responsible for ensuring all policies and procedures are in compliance with appropriate FDA, AATB, states, and Stability Biologics standard operating procedure.

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PRINCIPAL RESPONSIBILITIES

 

• Perform environmental monitoring activities

• Receive and verify donated human tissue

• Conduct incoming inspections

• Perform in-process testing and control

• Perform lot release testing

• Conduct testing on supplies

• Maintain QC Lab

• Review and analyze test results and reports

• Verify labeling and various manufacturing activities and document results

• Initiate Non-conformances and participate in investigations

• Scan products, transfer lots physically and electronically transfer in databases.

• Maintain equipment files and records

• Monitor and document facility and storage temperatures

• Prepare trends and graphs.

• Performs in-house preventative maintenance and calibration on QC equipment.

• Performs equipment qualification on new equipment (IQ/OQ/PQ).

• Drafts test reports for any test performed.

• Logs test samples into testing database.

• Orders supplies for quality control testing.

 

REQUIRED SKILLS & KNOWLEDGE

 

At least 1 year QC experience and a High School diploma