Job Description

Job Title: Quality Control Lab Technician

Department: 6500 Quality Control

Reports to: QC Lab Manager

Incumbent:

Job Summary: Checks all production batches and finished product to assure quality control in accordance with internal SOP’s and FDA/GMP requirements, and performs instrumental analyses as needed.

Essential Functions/Key Responsibilities:

1. Test and adjust production batches as required by formula and SOP. Communicate and record adjustments as required.

2. Test finished products, stability and validation samples using required methods.

3. Perform instrumental analyses as needed using HPLC, GC or TOC.

4. Complete all paperwork, record keeping and posting associated with approving and releasing batches.

5. Evaluate data for trends and author standard operating procedures and microbiological test methods.

6. Approve tankers for loading and unloading; record information and testing results.

7. Test products based on customer complaints or returns as needed, and retest returned goods for release or rejection as authorized.

8. Store samples as required and assist in maintaining retained samples as needed.

9. Maintain cleanliness and stock QC area and lab with materials as needed.

10. Assist in environmental monitoring to include obtaining samples and conducting testing for chemical or micro evaluation.

11. Operate computer programs in performance of administrative duties to prepare, distribute, and maintain forms, charts, logs, graphs and other written tools.

12. Responsible for assisting in the company’s compliance to current Good Manufacturing Practices.

13. Communicate to other shifts as needed concerning special microbiological testing and any pertinent issues.

14. Other duties as required or assigned, may include special analytical projects and validations.

All TeamMates of Kutol Products are expected to meet our customer-focused, quality goals through teamwork and continual improvement.

Core competencies/Requirements:

Education and experience:

• Bachelor of Science degree in chemistry or closely related discipline

• Minimum 12th grade proficiency in reading & math

Knowledge/Skills & ability:

• Knowledge of basic laboratory equipment operation and calibration (pH meters, viscometers, thermometers, etc.)

• Knowledge of laboratory glassware and proper usage (e.g. pipets, burets, beakers, etc.)

• Knowledge of current Good Manufacturing Practices

• Knowledge of applicable chemical and raw materials helpful

• Working knowledge of various testing apparatus including HPLC, GC, TOC

• Knowledge of sampling and testing procedures

• Strong analytical abilities and math skills

• Organized and detail-minded

• Self-starter with ability to work independently

Physical/Mental Requirements:

• Hand-eye coordination (computers)

• Combination: sit – 20% stand/walk – 80%

• Able to effectively balance and prioritize multiple tasks, deadlines, and interruptions simultaneously

• Ability to climb ladders daily; bend; lift Infrequent up to 50 pounds