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 115,000 colleagues serve people in more than 160 countries.
JOB DESCRIPTION:
A healthy heart is essential to good health. That's why we're committed to advancing treatments for people with cardiovascular disease. As a global leader in Cardiac Rhythm Technologies, our breakthrough medical technologies help restore people's health so they can get back to living their best lives, faster. We focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.
At Abbott, you can do work that matters, grow, and learn, care for yourself and 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 .
Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
An excellent retirement savings plan with 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.
This Quality Assurance Unit for the Cardiac Rhythm Technology (CRM) division will work off our Ventura County (CA) location.The Quality Assurance Unit works without appreciable supervision per established policies/procedures, fulfilling the quality assurance unit function for a non-clinical research facility to ensure compliance with applicable regulatory requirements, Good Laboratory Practices (GLP), and corporate and site policies/practices. Recommends, interprets, and implements site-specific policies and procedures to accomplish assignments; resolves a broad range of issues and problems. Identifies and routinely uses the most effective, cost-efficient, and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Promotes the process of continuous quality improvement and coordinates solutions for quality assurance audits or inspections. Exercises sound judgment in planning, organizing, and performing work; monitors performance and reports status within designated areas of responsibility.
WHAT YOU’LL DO
Develop and implement Quality Assurance (QA) procedures to ensure site GLP compliance. Train site personnel on QA related procedures and GLP regulations
Monitor facilities, personnel, methods, practices, records, and process controls for GLP compliance. Conducts and documents periodic internal audits and provide status reports to facility management
Make recommendations for correcting deficiencies and addressing deviations. Documents corrective actions taken. Plan, conduct, and report audits for vendors, suppliers, and contractors
Audit raw data and data collection procedures for accuracy and integrity
Ensure proper documentation and authorization and documentation of GLP, protocol and SOP deviations
Review final study reports to assure compliance with applicable regulations, confirm adequate descriptions of study methods, and verify accurate reflection of the raw data
Provide QA statement for study reports. Maintains a copy of the master schedule; and other QA-related documents. Schedules and tracks quality assurance audits (internal/external, GLP, document control), inspections, and findings
Participate in and lead support teams for internal and external inspections of the site. Audits training programs, training documentation, and site archiving processes
Remain current on developments in field(s) of expertise, regulatory requirements, as well as industry trends. Train staff on changing regulations and current best practices as related to medical research activities
Maintain knowledge of current and pending regulations through literature, trade journals, professional associations, and by attending conferences. Resolves and/or facilitates resolutions Performs related duties, on occasion, as assigned or required
Qualifications:
Bachelor’s Degree in Science or higher
Minimum 5 years experience working in the quality assurance or advanced credentials in a quality control processes, quality assurance, or quality system development and maintenance
Desire to work in a responsive and fast-paced environment
Proven ability to manage multiple projects/tasks at one time and oversee compliance
Good time-management skills and demonstrated ability to provide deliverables within specified timelines
Detail-oriented individual with a dedication to quality
Motivated self-starter with a strong work ethic
Excellent written and oral communication skills
Preferred
Experience working in the quality department of a GLP/GCP environment
Some years industry (pharmaceutical or CRO) experience, with knowledge and experience in a GLP environment
Previous experience working with medical devices
Registered Quality Assurance Professional in Good Laboratory Practices (RQAP-GLP) certification
Advanced knowledge of 21 CFR Part 11 and familiarity with quality management of computerized systems is an asset.
Apply Now
* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
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 and @AbbottGlobal.
The base pay for this position is
$82,100.00 – $164,100.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
CRM Cardiac Rhythm Management
LOCATION:
United States > Sylmar : 15900 Valley View Court
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes, 5 % of the Time
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
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), Routine work with chemicals, 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
