Title: Manufacturing Tech I

Reports to: Manufacturing Manager

Education Requirements: Technician position requires a minimum of a 2-year science related degree or relevant previous experience to indicate competency in laboratory/manufacturing procedures.

• Experience with ELISA, Cell Culture, and/or Western Blot preferred.
• Ability to analyze and interpret data and results
• Proficiency in excel
• Solid organization and analytical skills
• Ability to stand for 8 hour shift

Individuals serving in this position will be responsible for timely and accurate manufacturing of components ELISA, IFA, Western Blot and LIA kits, Cell biology as well as in-process quality testing and documentation reporting directly to the Manufacturing Manager. Employees will be trained in a variety of manufacturing processes covering the various product types, and all kit assembly procedures, including vialing, labeling and assembly.

1. Execution of quality system production procedures for the department as assigned by departmental supervisor including:
   1. Product Manufacturing
   2. Use / Monitoring of departmental equipment as required by QAPs and SOPs
   3. Quality documentation procedures
   4. Raw material testing
2. Demonstration of competence with equipment and procedures
3. Proper execution of SOPS and QAPs for manufacturing procedures assigned by supervisor.
4. Demonstration of sound problem-solving skills and troubleshooting abilities.
5. Adherence to quality systems with special regard to FDA, ISO 9000 / 13485 and GMP / OSHA compliance.
6. Production / Work order entry
7. Assay data analysis
8. Supply management / PO submission
9. Focus on continual process improvement
10. Cleaning and maintenance of equipment
11. Washing of production glassware
12. Cross train and provide backup to other departments as required.
13. Other duties as assigned