Assembly Line/Operations Associate

The Assembly Line/Operations Associate I  is located in Mt. View, CA.  This position will receive general instructions for routine work and will use current Good Manufacturing Practices and Standard Operating Procedures to perform a variety of production line tasks to include part assembly, labeling, packaging, inspections and lot accountability. along with maintaining batch records to comply with regulatory requirements. This position will also assist with product shipments and the staging of production order materials.  This position may be exposed to blood serum, hazardous chemicals, and loud noises. Benefits include Medical, Dental, Vision, 401K, Life Insurance, etc.

Essential Duties and Responsibilities: 

• Perform routine visual inspection on in-process materials according to documented specifications
• Communicate effectively with co-workers and supervisor
• Communicate with supervisor and department lead regarding any excessively damaged or substandard assembly work and defective parts, tools, equipment, material, or other conditions which hinder the assembly process
• Respond in a timely manner to manufacturing needs.  Maintain, operate, and troubleshoot production and test equipment. Clean and maintain work area and equipment. Perform line clearances and inspect components
• Package and assemble diagnostic test kits; operate production-line machinery and computers according to cGMP, batch records, Manufacturing Operating Procedures and safety policies
• Follow and provide feedback on Standard and Manufacturing Operating Procedures, Work Instructions, Manufacturing Batch Records
• Organize and maintain maintenance and cleaning logs for manufacturing equipment
• Assist with: International and Domestic shipments;  routine inventory cycle counting – weekly, quarterly and end of year physical count and with pulling/staging of Manufacturing materials for production orders

 Position Requirements (Knowledge, skills and abilities required to perform satisfactorily in the position):

• Working knowledge of cGMP requirements (preferred)
• Ability to follow instructions and communicate clearly and concisely in English (oral and written)
• Basic knowledge and experience with PC and Microsoft applications (Excel, Word and Outlook are required)
• Basic reading, writing in English, arithmetic, and critical thinking skills
• Detail oriented, ability to reconcile and document daily tasks
• Manual dexterity required for quick, accurate assembly of small parts and operation of equipment

 Education and Experience:

• High School Diploma (Prefer AS or equivalent college course work in Chemistry or Life Sciences) 
• Minimum one (1) year experience in a cGMP Manufacturing environment of the biotech or pharmaceutical industry (preferred)

 Supervisory Responsibility:

N/A

 Work Environment:

• Manufacturing/Warehouse environment
• Dry temperature and cold temperature (2-8 degrees) on occasion
• Loud noises (occasional)
• Potential exposure to human blood serum, ozone, and hazardous chemicals
• Machinery operation requires the use of safety equipment to include, but not limited to lab coat, eye safety-glasses, slip-resistant safety shoes, and hearing protection

 Physical Demands:

• Frequently lift up to 25 pounds (for up to 2 hours at a time and up to 8-10 hours total in a day)
• Frequent use of hands (for up to 2 hours at a time and up to 8-10 hours total in a day)
• Long periods of standing (continuously for up to 2 hours at a time and up to 8-10 hours total in a day)
• Ability to visually discern printed characters as small as 1/16”; Close and distant.
• Ability to work in a cold room environment (2-8 degrees) for a period of up to 2 hours at a time.

 Position type and expected hours of work: 

Full-time.  Must be able to work flexible schedules (including occasional nights, weekends, overtime) as needed.

 Travel Demands: 

N/A

Disclaimer

The above statements are intended to describe the general nature and level of the work being performed by people assigned to this work. This is not an exhaustive list of all duties and responsibilities. Canon Medical Diagnostics USA management reserves the right to amend and change responsibilities to meet business and organizational needs as necessary, at any time with or without notice.