Quality Control Technician

General :

The Quality Control Technician is responsible for ensuring the quality, accuracy, and compliance of all incoming materials, in-process production, and finished repackaged products in accordance with Good Manufacturing Practices (cGMP), company procedures, and regulatory requirements. This role plays a critical part in maintaining product integrity, preventing errors, and ensuring customer satisfaction through meticulous inspection, verification, and documentation.

Responsibilities and Duties:

• Possesses a thorough understanding of current Good Manufacturing Practices (cGMP).
• Demonstrates proficiency in all relevant computer programs, logs, and folders used within the department (e.g., Prepack Management System, RemedyRepack NDC system).
• Checks the accuracy of all incoming product/materials received for repackaging against accompanying documentation.
• Visually inspects all incoming products for any signs of adulteration, misbranding, counterfeiting, or damage.
• Verifies that the correct product and quantity were received against packaging paperwork.
• Assigns National Drug Codes (NDCs) for new drugs and new counts within the Prepack Management System.
• Ensures all information pertaining to the manufacturer drug product NDC corresponds with the assigned RemedyRepack NDC across all computer systems.
• Understands and adheres to Quarantine procedures for non-conforming drug products and materials.
• Understands the procedure for processing controlled substances, ensuring strict adherence to regulations.
• Accurately creates Batch Production and Control Record Forms for all production runs.
• Prints Master Production Records for each production run and ensures their accuracy.
• Orders all pre-printed cards in the Prepack Management System.
• Prints and verifies the accuracy of all batch labels.
• Stages all production runs according to FIFO (First-In, First-Out) order.
• Performs a "PrePack Check Routine" before all production runs, ensuring proper batch/drug combination.
• Verifies and approves all Master Production Records prior to production.
• Monitors Machine Operating Technicians and Production Technicians' batch run preparations to ensure continuous production throughout the shift.
• Performs line clearance, releasing equipment and stations for the next batch.
• Performs end-of-day line clearance, releasing equipment and stations to the next shift.
• Re-labels products as needed, ensuring accuracy and compliance.
• Performs final release of all repackaged and relabeled product batches.
• Performs post-pack validation in the Prepack Management System, ensuring all batches are finalized within the system.
• Ensures all labels containing drug information are accounted for, and all extra labels are recorded and disposed of properly.
• Ensures all batch records are completed and accurate, with all necessary signatures obtained.
• Demonstrates a thorough understanding of the responsibilities of the Quality Unit.
• Maintains the confidentiality of company information.
• Maintains a neat and clean personal appearance.
• Performs all other duties as assigned.
• Possesses a thorough understanding of current Good Manufacturing Practices (cGMP).
• Demonstrates proficiency in all relevant computer programs, logs, and folders used within the department (e.g., Prepack Management System, RemedyRepack NDC system).
• Checks the accuracy of all incoming product/materials received for repackaging against accompanying documentation.
• Visually inspects all incoming products for any signs of adulteration, misbranding, counterfeiting, or damage.
• Verifies that the correct product and quantity were received against packaging paperwork.
• Assigns National Drug Codes (NDCs) for new drugs and new counts within the Prepack Management System.
• Ensures all information pertaining to the manufacturer drug product NDC corresponds with the assigned RemedyRepack NDC across all computer systems.
• Understands and adheres to Quarantine procedures for non-conforming drug products and materials.
• Understands the procedure for processing controlled substances, ensuring strict adherence to regulations.
• Accurately creates Batch Production and Control Record Forms for all production runs.
• Prints Master Production Records for each production run and ensures their accuracy.
• Orders all pre-printed cards in the Prepack Management System.
• Prints and verifies the accuracy of all batch labels.
• Stages all production runs according to FIFO (First-In, First-Out) order.
• Performs a "PrePack Check Routine" before all production runs, ensuring proper batch/drug combination.
• Verifies and approves all Master Production Records prior to production.
• Monitors Machine Operating Technicians and Production Technicians' batch run preparations to ensure continuous production throughout the shift.
• Performs line clearance, releasing equipment and stations for the next batch.
• Performs end-of-day line clearance, releasing equipment and stations to the next shift.
• Re-labels products as needed, ensuring accuracy and compliance.
• Performs final release of all repackaged and relabeled product batches.
• Performs post-pack validation in the Prepack Management System, ensuring all batches are finalized within the system.
• Ensures all labels containing drug information are accounted for, and all extra labels are recorded and disposed of properly.
• Ensures all batch records are completed and accurate, with all necessary signatures obtained.
• Demonstrates a thorough understanding of the responsibilities of the Quality Unit.
• Maintains the confidentiality of company information.
• Maintains a neat and clean personal appearance.
• Performs all other duties as assigned.

Qualification:

Education:

High School Diploma or Equivalent Experience/Knowledge:

• Trained and qualified on RemedyRepack Quality Unit.
• Ability to organize one's own work
• Excellent communication skills both verbal and written
• Strong ability to multitask
• Reliability and honesty
• Accuracy and detail oriented

Physical Requirements:

In an 8-hour day the employee:

• May lift/carry up to 20 lbs. frequently
• Stands/walks 10%-20% of the time
• Sits 80%-90% of the time
• Drives a car/truck 0% of the time Equal Opportunity Employer including individuals with Disabilities and veterans.

Benefits:

401(k) matching Dental insurance Employee discount Health insurance Health savings account Life insurance Paid time off Vision insurance

Work Location:

In person