Quality Assurance Specialist I

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 114,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Quality Assurance Specialist I Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. Youll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with a high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelors degree. A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity The position of Quality Assurance Specialist I is within our CMI Unit located in Pomona, California. This role will support site QA activities and primarily focus on one or more key quality subsystems, including document control, training, complaints, nonconformances, CAPA and/or supplier control. WHAT YOULL DO Responsible for implementing and maintaining the effectiveness of the Quality System. Participate in Quality System processes which may include training, corrective action and preventive action (CAPA) activities, equipment maintenance, product and process planning, quality audits, validation. Aid in implementing process improvements with respect to Quality Assurance processes. Maintain Quality metrics as required. Manage and/or assist with complaints, CAPA, change requests, NCMRs, deviations. Provide support to QA activities for regulatory compliance (i.e. Management Review support, regulatory audits). Assist in determining quality attributes and requirements. May provide technical assistance. Utilize quality management techniques to perform investigations and facilitate solutions. Work with managers to coordinate training requirements for employees as required. Manage training program and organizational chart as required. Perform Quality System Training Requirements as needed. Review/approve supplier surveys and make recommendations as required. Assist with internal audits and agency audits. Manage Document Control as required. Recognizes risks versus the relative gains associated with actions; understands a project's critical success factors and makes recommendations and decisions impacting those factors. Drives functional performance to ensure that cross-functional standards and expectations are met. May assist in the training of personnel as directed by management. Responsible for completing documentation in a timely manner and in accordance with business standards. Manage equipment maintenance and calibration program as required. Assist with equipment, process and facility qualification and validation activities as required. 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. 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. 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. Required Qualifications: BS/BA degree in chemistry, biology, or other scientific discipline or equivalent combination of education and work experience. 0-2 years experience in Quality Assurance or Regulatory Compliance experience in a manufacturing environment, preferably in vitro diagnostics. 0-4 years of relevant work experience in assigned subsystem(s). Writing and Communication Skills (e.g. write technical reports, present data analysis). Experience with MS Office including excel and power point. Must be detail-orientated, self-motivated and available for flexible scheduling. Preferred Qualifications Knowledgeable of federal and other regulations, e.g. QSRs, ISO, ISO 13485, CMDR. Demonstrated initiative and problem-solving skills. Ability or aptitude to use various types of databases and other computer software. Strong organizational skills. Ability to clearly, concisely and accurately convey communications. Knowledge of quality management techniques and application. Able to work on multiple tasks as a team member and/or ability to operate as an individual contributor. COMPETENCIES: Drives for results Attention to detail Initiative Communication Adaptability Apply Now Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews. The base pay for this position is $72,100.00 $114,700.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY: Operations Quality DIVISION: CMI ARDx Cardiometabolic and Informatics LOCATION: United States > Pomona : 829 Towne Center Drive ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday), Work in a clean room environment, Work in noisy environment Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions across the spectrum of health, around the world, for all stages of life. Whether its next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of lifes greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. Follow Us: Facebook LinkedIn YouTube Twitter