Maintains labeling processes and documentation to meet QMS, Global Regulations, and Compliance requirements. Under general direction, establishes, develops and implements labeling process improvements with the most optimal effectiveness. Consults with internal/external groups to align solutions that improve processes and techniques. Perform labeling assessments and charter projects that improve processes to support business and department initiatives. Leads the development of labeling training m... more details
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:
Working at Abbott
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.
The Opportunity
This position is an onsite opportunity in the Abbott Diabetes Care Division. We are helping people with Diabetes lead healthier, happier lives. As a global leader in diabetes care, Abbott is constantly working to deliver the highest quality products and unwavering support to our customers. Consistent and accurate glucose monitoring is the foundation of any diabetes management plan, so we’re committed to continuous improvement in the way patients and professionals measure, track and analyze glucose levels.
As a Labeling Process Improvement Specialist, you will be responsible for managing Artwork & Labeling Development departmental processes and maintains the continuous improvement philosophy to meet internal and external initiatives & requirements at Abbott Diabetes Care. This is an onsite opportunity in Alameda, CA.
What You'll Do
- Maintains labeling processes and documentation to meet QMS, Global Regulations, and Compliance requirements.
- Under general direction, establishes, develops and implements labeling process improvements with the most optimal effectiveness. Consults with internal/external groups to align solutions that improve processes and techniques.
- Perform labeling assessments and charter projects that improve processes to support business and department initiatives.
- Leads the development of labeling training materials and tools to support the implementation of projects.
- Author/revise labeling documentation (e.g. Procedures, SOP(s), Specifications, etc.) to meet the Division’s needs
- Creates and modifies documentation supporting process and requirements for product labels, cartons, and other related materials ensuring that they meet all medical, legal, and regulatory requirements for medical devices/in vitro diagnostic devices (IVDs) following the established creative design format and brand guidelines
- Complies with U.S. Food and Drug Administration (FDA) regulations, other global regulatory requirements, company policies, operating procedures, processes, and task assignments.
- Adapts precedent and may make significant departures from traditional approaches to develop innovative solutions.
- Participates in external organizations, conferences and seminars to keep current with industry best practices of industry developments in packaging artwork, labeling technologies and regulations.
- Contributes to strategic planning for compliance when needed.
- Estimates project levels of effort and resource requirements by using standard estimating techniques and tools, and by working with appropriate staff to understand scope of effort.
- Prepares project plans, schedules and budgets by using project management tools such as Microsoft Project and by working with appropriate staff to understand tasks necessary to complete project.
- Plans and organizes project assignments of substantial variety and complexity.
- Directs project execution by assigning tasks, tracking project schedules, identifying risks, and developing and executing contingency plans.
- Initiates or maintains schedule for projects and project milestones. Establishes priorities of individual or project assignments. Selects methods and techniques to lead a project to completion.
- Ability to execute highly complex or specialized projects.
- Strong organizational and human relations skills. Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Strong written and oral communication skills and ability to present to management and to extended teams.
Experience You'll Bring
Required
- Bachelors Degree in engineering, science, or technical related field.
- Minimum 5 years of experience in design/process verification and validation in a regulated environment such as Medical Devices, Pharmaceutical Products or Food Manufacturing.
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.
Divisional Information
Medical Devices
General Medical Devices:
Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine ?ngersticks.
CRM
As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.
Diabetes
We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.
Vascular
Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease.
Neuromodulation
Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum.
Structural Heart
Structural Heart Business Mission: why we exist
Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.
EP
In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.
HF
In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives.
Diagnostics
We’re empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.
Abbott Molecular is a leader in molecular diagnostics and the analysis of DNA, RNA, and proteins at the molecular level.
Our Point of Care diagnostic portfolio spans key heath and therapeutic areas, including infections disease, cardiometabolic, informatics and toxicology.
Our diagnostic solutions are used in hospitals, laboratories and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.
Our rapid diagnostics solutions are helping address some of the world’s greatest healthcare challenges.
Nutrition
Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get the nutrients they need to live their healthiest lives.
The base pay for this position is
$95,500.00 – $190,900.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
ADC Diabetes Care
LOCATION:
United States > Alameda : 2901 Harbor Bay Parkway
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes, 10 % of the Time
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
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
