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Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countriesAbbott Rapid Diagnostics 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.The position of Supervisor, Quality Assurance is within our Toxicology business unit located in Pomona, CA. This role is responsible for supervising specific quality systems.This job description will be reviewed periodically and is subject to change by management.RESPONSIBILITIES:
- Manage specific quality systems, i.e., Incoming Inspection, in-process and Final Product Release, etc.
- Supervises and oversees the activities of the batch record reviewers and the incoming inspectors
- Provides input and recommendations on incoming inspection forms and procedures
- Reviews and approves change orders
- Develops and reports batch record review performance indicator metrics to management team
- Provides secondary support for other quality subsystems
- Maintains quality system records through the establishment, maintenance of a centralized documentation archiving system
- Manages physical quality system records for cataloging, archival, retrieval and scheduled destruction of records in accordance with established procedures
- Reviews and maintains documents used in GMP
- Provides support during regulatory inspection activities
- Manages performance of staff towards department and Company goals, including feedback on performance, appraisals, recommendations for merit increases or necessary disciplinary actions, communication to employees on performance, etc.
- Carries out duties in compliance with established business policies
- Demonstrates commitment to the development, implementation and effectiveness of Alere Quality Management System per ISO, FDA, and other regulatory agencies
- 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
- 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.MINIMUM QUALIFICATIONS | EDUCATION/EXPERIENCE:
- Bachelor’s Degree in related discipline or equivalent experience
- At least 3 or more years of experience with at least 1 year of progressively responsible positions in Quality Assurance
- At least 3 or more years of experience in a lead or supervisory position
- Working knowledge of Quality Assurance in a medical device manufacturing environment, preferably in-vitro diagnosticsPREFERRED QUALIFICATIONS:
- Excellent written and verbal communication skills
- Expert in using computers, specifically MS Office (MS Word/Excel)
- Able to understand and adhere to quality documentation
- Position requires ability to jointly develop, implement, evaluate, and/or modify on going “best practices” to assure overall operational effectiveness
- Knowledge of the QSR or ISO 13485 is a plus
- Excellent organization skills – must be able to manage many simultaneous projects
- Attention to detail – must have precision in their work, especially as it relates to understanding and documenting complex quality issuesCOMPETENCIES:
- Leadership
- Initiative
- Drives for results
- High level of attention to detail
- CollaborationAbout 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 EmployerAbbot 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
