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Abbott Quality Assurance Specialist II in San Diego, California

DO WORK THAT MATTERS

At Abbott, diverse ideas, perspectives, and expertise allow us to create the life-changing solutions that help people live healthier lives. In 160 countries and with businesses spanning nutrition, diagnostics, medical devices, and branded generic pharmaceuticals, Abbott offers you enormous opportunities to explore your interests and help you achieve your career and personal goals.

We have an exciting opportunity for a Quality Specialist II within our Abbott Rapid Diagnostics business located at San Diego, CA . In this role, you will be focused on supporting change control and document control process and improvements with respect to Quality Management System procedures, and generate or revise quality control related documents as needed.

Abbott Rapid Diagnostics (formerly Alere) is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.

RESPONSIBILITIES

  • Support document control process and improvements with respect to Quality Management System procedures

  • Maintain quality metrics as required

  • Manage and/or assist with change controls, DCO’s and documents periodic reviews.

  • Provide support to quality assurance activities for regulatory compliance, (i.e. management review support, regulatory audits)

  • Work with managers to coordinate document reviews and approval prioritization as required

  • Manage archiving, obsolescence and document storage.

  • Perform Quality System Training on document or system updates as needed

  • Review/approve document changes and make recommendations as required

  • Assist with internal audits and agency audits

  • Assist with documents related to equipment, process and facility qualification and validation activities as required

  • Review raw material specification quality control forms

  • Mentor and train junior level associates

  • Carries out duties in compliance with established business policies

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

  • Perform other duties and projects as assigned

BASIC QUALIFICATIONS

  • BS/BA degree or equivalent or equivalent experience

  • Minimum of 2 years’ experience in Quality Assurance or Regulatory Compliance experience in a manufacturing environment, preferably in vitro diagnostics or FDA regulated industry with 1-3 years of progressively responsible positions.

  • Minimum of 3 years of experience in change control and documentation practices on a regulated environment.

PREFERRED QUALIFICATIONS

  • Knowledgeable of federal and other regulations, e.g. QSR’s, ISO, ISO 13485, CMDR

  • Experience with 21 CFR 820, ISO 13485

  • Able to work on multiple tasks as a team member and/or ability to operate as an individual contributor

  • Goal oriented, learns quickly, works in a collaborative manner with other departments.

  • Strong writing and verbal communication skills.

  • Must be detail-orientated, self-motivated and available for flexible scheduling

  • Proficient with Microsoft Office, including Word, Excel, PowerPoint and Visio

COMPETENCIES

  • Analytical skills

  • Drives for results

  • Attention to detail

  • Initiative

  • Communication

  • Adaptability

About Abbott

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 130 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 107,000 of us are working to help people live not just longer, but better, in the more than 160 countries we serve.

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities. To request an accommodation, please send an email to myrecruiter@alere.com

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com

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