Manufacturing Technician I - Assay

Job Description

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/Qualifications:

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 shiftSummary of Position:

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.

Job Duties/Key Responsibilities:

Execution of quality system production procedures for the department as assigned by departmental supervisor including:

Product Manufacturing

Use / Monitoring of departmental equipment as required by QAPs and SOPs

Quality documentation procedures

Raw material testing

Demonstration of competence with equipment and procedures

Proper execution of SOPS and QAPs for manufacturing procedures assigned by supervisor.

Demonstration of sound problem-solving skills and troubleshooting abilities.

Adherence to quality systems with special regard to FDA, ISO 9000 / 13485 and GMP / OSHA compliance.

Production / Work order entry

Assay data analysis

Supply management / PO submission

Focus on continual process improvement

Cleaning and maintenance of equipment

Washing of production glassware

Cross train and provide backup to other departments as required.

Other duties as assigned