Laboratory Assistant

Canon Medical Diagnostics USA Inc•Mountain View, CA

24d•$22 - $24•Onsite

About The Position

The QA Lab Assistant is responsible for in-process/final product testing and disposition using an MRP system. This role requires tasks to be completed in a timely manner and work assignments to be reprioritized based on the needs of the manufacturing schedule. The preferred candidate should have knowledge of cGLP with an understanding of equipment calibration.

Requirements

Ability to manage tasks from beginning to end within established timeline.
Ability to work independently and cohesively in a team environment.
Ability to calculate using algebra, statistics, weights / measures and the metric system and apply logic during data analysis.
Ability to use Microsoft Office (Outlook, Excel, Word) and Visio.
Ability to use micro-centrifuges.
Ability to communicate in English (verbal and written).
Effective problem-solving and decision-making skills.
Performs additional duties as necessary.

Nice To Haves

Basic understanding of 21 CFR 820, ISO 13485.
Knowledge of cGLP/GDP.
AS /BS Degree
Working knowledge in quality control environment
2 years of experience in FDA regulated manufacturing environment

Responsibilities

Follow detailed procedures and processes.
Inspect, test, and release in-process and final product 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 and document test results, problems and other relevant information.
Maintain laboratory equipment to assure accuracy and confidence.
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.
Perform document changes and revisions.