- 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
- 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
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Description
Job Description
Job DescriptionTitle: 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: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: