Quality Assurance Specialist I (2nd shift)

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POST DATE 8/11/2016
END DATE 11/11/2016

Alere San Diego, CA

Company
Alere
Job Classification
Full Time
Company Ref #
08356
AJE Ref #
575846569
Location
San Diego, CA
Experience
Entry Level (0 - 2 years)
Job Type
Regular
Education
Bachelors Degree

JOB DESCRIPTION

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JOB SUMMARY

Under minimum supervision this position is responsible for Quality Assurance activities including implementation of process improvements, improving supplier quality and monitoring and measuring Ameditech compliance within Quality System Regulations, Ameditech Quality policies, FDA and ISO regulations as well as Ameditech product quality and compliance objectives.

The schedule of this position is 2nd shift, 3pm-11:30pm Monday to Friday.



TASKS AND RESPONSIBILITIES:

* As needed, assist with complaints, CAPA, change requests, NCMRs, deviations

* Provide support to QA activities for regulatory compliance, (i.e. Management Review support, regulatory audits).

* Work with managers to coordinate training requirements for employees

* Assist with managing the training program

* Assist with internal audits and agency audits.

* Perform Document Control activities as needed such as processing documents and filing

* Review and disposition batch records

* Review Raw Material Specification

* Maintain equipment/calibration files and log

* Other responsibilities as assigned

* Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the companys policies and practices.

PREFERRED EDUCATIONAL BACKGROUND:

BS degree in science or related field or equivalent experience



PREFERRED EXPERIENTIAL BACKGROUND:

* 1-2 years of Quality Assurance experience in manufacturing environment, preferably in vitro diagnostics

* Experience in a GMP type environment (production, lab) preferred

* Knowledgeable of federal and other regulations, e.g. QSRs, ISO, ISO 13485, CMDR

* Experience with 21 CFR 820, ISO 13485