QA Specialist I

Description:

RESPONSIBILITIES:

Responsible for running in-process, stability/calibration, final release, and experimental devices

Notifying appropriate personnel of results and completing all associated data and documentation

Cross-trained on all processes including in-process, stability, calibration, and final release

Able to solve process-related questions/problems and minor investigations

Review device history records

Train new employees/Quality Control Technician I

Operate laboratory equipment safely, as trained and directed, in accordance with established practices

Responsible for inventory of all testing related materials

Demonstrates commitment to the development, implementation and effectiveness of Alere Quality Management System per ISO, FDA, and other regulatory agencies

Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities

Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices; build productive internal/external working relationships

Carries out duties in compliance with established business policies

Other duties as assigned, according to the changing needs of the business

MINIMUM QUALIFICATIONS | EDUCATION/EXPERIENCE:

Minimum Education:

High School/ GED graduate or equivalent

Minimum Experience:

2 - 5 years relative work experience

PREFERRED QUALIFICATIONS:

BS in a science-related field

2 - 5 years of laboratory experience in quality control/assurance or a manufacturing environment, preferably invitro diagnostics

Proficient with Microsoft Office Suite; strong knowledge of Excel

Organized and detail oriented

Ability to work in a team environment

Able to multitask and adapt to changes in task priorities

COMPETENCIES:

Continually develops his/her own skillset.

Acts ethically and takes accountability for achieving outcomes.

Actively develops a network to bring best solutions to the team or customer.

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