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Hitachi

Hitachi Chemical Diagnostics, Inc. Hitachi Chemical Diagnostics, Inc.

Jobs

Title: QA Chemist I
Reports to: QA Lab Supervisor
Department: Quality Assurance
Status: Non-Exempt

General Summary/Objective (Purpose of position)

The QA Chemist I should have working knowledge of GLP with an understanding of equipment calibration and willingness to support other functional groups. The individual will be responsible for in-process and final product test and disposition. Additionally, the individual is expected to approve/release incoming raw materials with the use of an MRP system.

Essential Duties and Responsibilities

  • Inspect, test, and release in-coming materials in a timely manner
  • Approve materials and in-process parts in MRP.
  • Identify non-conforming materials and protocol / procedural errors
  • Evaluate analytical results and determine conformance to specification
  • Identify deviations and out of specifications events
  • Document test results, problems and other relevant information
  • Maintain laboratory equipment to assure accuracy and confidence in performance

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

  • Basic understanding of 21 CFR 820, ISO 13485, MHLW Ministerial Ordinance 169 and the IVD Directive
  • Knowledge of risk analysis/FMEA (preferred)
  • Ability to calculate using algebra, statistics, weights / measures and the metric system
  • Ability to use Microsoft Office (Outlook, Excel, Word) and Visio
  • Strong working knowledge of GLP/GDP.
  • Working knowledge of clinical analyzers (Luminometers preferred).
  • Ability to use micro-centrifuges.
  • Ability to apply logic during data analysis.
  • Ability to manage projects from beginning to end within established timeline.
  • Ability to communicate in English (verbal and written).
  • Effective problem-solving and decision-making skills.
  • Working knowledge of handling bio-hazardous materials (preferred)
  • Ability to work independently and cohesively in a team environment.
  • Ability to transact materials/product with an MRP system (AX Dynamics preferred)
  • Performs additional duties as necessary

Education and Experience

  • BA/BS in Biochemistry, Chemistry, or Biological Sciences with minimum of 2 years of experience in a FDA regulated manufacturing environment. (Prefer working knowledge in quality control environment)

Supervisory Responsibility

This position has no supervisory responsibilities.

Work Environment

  • Laboratory Environment
  • Exposure to blood-borne pathogens and hazardous chemicals.
  • Exposure to a cold room (2-8°C) environment for up to 30 minutes continuously at a time
  • Must wear protective equipment such as safety glasses, laboratory coats, hairnets, hard hats, face shields and any relevant equipment deemed as necessary.

Physical Demands

  • Ability to lift up to 30 pounds (totes/containers)
  • Ability to work in a cold room (2-8°C) environment for up to 30 minutes continuously at a time
  • Prolonged viewing of computer screen
  • Frequent use of mouse and keyboard
  • Ability to sit or stand, up to 2 hours continuously at a time and up to 8 hours or more in a day
  • Specific vision abilities include close vision, and the ability to adjust focus

Position type and expected hours of work

Full Time

Travel Demands

None

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.

  • Regularly cleans and maintains a neat and organized work area
  • Participates in continuous improvement activities
  • Participates in the development, implementation and maintenance of Quality Systems and other Quality Assurance activities
  • Coordinates work assignments to meet production timelines
  • Performs customer complaint testing
  • Assists in writing inspection protocols and validations
  • Maintains laboratory inventory and orders supplies, as needed
  • Performs basic equipment inspections and troubleshooting
  • Performs initial troubleshooting of issues which arise during routine analysis

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.