Quality Control Technician II

Reports to: Quality Control Supervisor

Education Requirements: Technologist position requires a minimum of a Bachelor’s of Science degree in Medical Laboratory Technology, Biotechnology or one of the Chemical, Physical, or Biological Sciences and relevant previous experience to indicate competency in laboratory procedures.

Experience/Qualifications:  

• 1-2 years laboratory experience beyond lab coursework in the form of internships, undergraduate/ graduate research, or post-collegiate employment.
• Experience with ELISA, IFA, and Western Blot is preferred.
• Ability to analyze and interpret data and results.
• Proficiency in Excel.
• Solid organization and analytical skills.

Physical Effort:  Listed below are the physical demands of the job according to percentage of time performing the tasks including any applicable weight movements.

Summary of Position:

Timely and accurate performance of quality control testing under supervision of the QC Supervisor.

Job Duties/Key Responsibilities:

1. Execution of quality system procedures for the department as assigned by departmental supervisor including:
   1. Quality documentation procedures
   2. Raw material testing
   3. Pull product to test
   4. Fill samples as needed
   5. Rejects in-process and finished goods if nonconformity with the specification is identified.
   6. Provides QC release of products for shipment to customers if product conforms to specifications.
   7. Complete Certificate of Analysis paperwork to accompany shipments.
   8. Folder review, log and file
   9. Handle customer complaints if necessary
   10. Performs a wide range of lab tests including Western Blot, Elisa, LIA/Lyme and IFA assays to determine if products conform to applicable requirements and specifications.
   11. Use laboratory equipment.
   12. Records QC testing results in appropriate manner as requested and signs off in appropriate sections of batch records and C of A’s, as required.
   13. Review of records necessary to indicate compliance with quality procedures.
2. Proper execution of SOPS and QAPs for quality control procedures assigned by supervisor.
3. Demonstration of sound problem-solving skills and troubleshooting abilities.
4. Setup, adjusts, operates, and maintains laboratory equipment used in quality testing and process control.
5. Adherence to quality systems with special regard to FDA, ISO 13485 and GMP / OSHA compliance.  Adheres to and fully complies with all company health and safety, environmental and quality procedures.
6. Assay data analysis
7. Focus on continual process improvement
8. Cleans lab equipment as necessary and performs housekeeping in lab and sample retention area and areas in which lab supplies and waste materials are stored.
9. Ensures that inventories of unexpired reagents, labels, customer sample kits, consumable spare parts for QC equipment, etc. that are used in the QC function are maintained at levels such that they don’t run out. 
10. Cross train and provide backup to other departments as required.
11. Other duties as assigned.