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ASD - Quality Assurance Specialist I
Ref No.: 18-07509
Location: San Diego, California
Job Title: Quality Assurance Specialist I
Location: San Diego, CA
Duration: 6 months plus possible extension
Shift: Monday-Friday 8-5

ASAP need

3 skillsets:
quality systems for med device
electronic tools- excel, powerpoint, word

supplier quality file maintenance
system separation activities
remediation, general remediation projects- help write and draft up
working with existing employee for support

clear instructional tasks- but general background in QA helpful

3 on panel interview onsite, no phone screen

Introduction All Roles:In all of our roles at Alere we are responsible for the full lifecycle of medical devices and services. Our customers (usually patients) rely on us to deliver exception service as they use our product to make life & health decisions. Whether we work in research, development, manufacturing or any one of our other functions the work we do on a daily basis can affect our customers. This job description gives you a top level, generic job summary and the typical skills, education or experience required to complete the role. The description in both the product quality impact and compliance sections are specifically related to the level of the role and the impact of not delivering on this part of the job can have a devastating effect for both our customers & our business.Summary Job Description:Assists and supports the organization with initial compliance and ongoing preparation, testing and monitoring of conformance to established quality assurance processes and standards for manufacturing and production. Performs evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards. Identifies risk and evaluates deficiencies while working with internal departments/business units to appropriately remedy them. Facilitates internal training on quality assurance requirements, processes, and procedures. May perform audits and risk assessments. Product Quality Impact: *** Please see Reference Library for full job descriptions***Compliance: All roles have responsibility for following documented procedures, maintaining records, highlighting areas of nonconformance, adhering to GxP and ensuring audit trails exists. Additional Compliance requirements: *** Please see Reference Library for full job descriptions***Additional: Other duties as required.Knowledge: Learns to use professional concepts. Applies company policies and procedures to resolve routine issues. Job Complexity: Works on problems of limited scope. Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained. Builds stable working relationships internally.Supervision: Normally receives detailed instructions on all work. Experience: Typically requires no previous professional experience.