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
