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. You’ll 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 bachelor’s 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 YOU’LL 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 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.
- 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. QSR’s, 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
$73,900.00 – $116,000.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
TOX ARDx Toxicology
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 environmentAbbott 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.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
