Hitachi Chemical Diagnostics, Inc.

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OPTIGEN Manufacturing Associate I

Title: OPTIGEN Manufacturing Associate I
Reports to: Operation Supervisor
Department: OPTIGEN Manufacturing
Status: Non-Exempt

General Summary/Objective (Purpose of position)

The OPTIGEN Manufacturing Associate I position is located in Mt. View, CA. This position will use current Good Manufacturing Practices to perform a variety of production line tasks to include part assembly, labeling, packaging, inspections and lot accountability. Work is performed in a clean manufacturing environment. The person in this position may be exposed to blood serum, hazardous chemicals and loud noises. The incumbent will receive general instructions for routine work.

The OPTIGEN Manufacturing Associate I will also maintain batch records to comply with regulatory requirements, current Good Manufacturing Practices, and Standard Operating Procedures.

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 excessive damaged or substandard assembly work and defective parts, tools, equipment, material or other conditions which hinder 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

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, both orally and in writing
  • 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 and 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

  • This position has no supervisory responsibilities.

Work Environment

  • Manufacturing environment
  • Dry temperatures (occasional)
  • 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, eye safety glasses, slip-resistant safety shoes, and hearing protectors

Physical Demands

  • Frequently lift up to 15 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

Position type and expected hours of work

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

Travel Demands

  • N/A

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Additional Information

Affirmative action plan/equal employer opportunity (AAP/EEO) statement

Hitachi Chemical Diagnostics, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Hitachi Chemical Diagnostics, Inc. complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

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. Hitachi management reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.