Job Description
- 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 113,000 colleagues serve people in more than 160 countries.
JOB DESCRIPTION:
Operations Process Development Scientist
Carlsbad, CA
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 countries
About Abbott
Diagnostic testing is a compass, providing information that helps in the prevention, diagnosis, and treatment of a range of health conditions.
Abbott's life-changing tests and diagnostic tools give you accurate, timely information to better manage your health. 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.
Our Carlsbad, CA, currently has an opportunity for an Operations Process Development Scientist position within our Cardiometabolic & Informatics business unit. This role will be responsible for new product and process transfers, agreeing on issues, and collaborating with R&D/Process development to ensure transfer timelines are created and achieved. This position is also responsible for supporting resolutions of production issues and product/production improvements that increase quality, lower cost and increase manufacturing capacity.
WHAT YOU'LL DO
- Coordinate and champion new product/process transfers. Ensure required documentation is complete. Collaborate with R&D/Process Development to establish transfer timelines consistent with targeted introduction date.
- Ensure new products/processes changes/technical issues are correctly characterized and appropriate actions are undertaken.
- Lead efforts to troubleshoot manufacturing and product/process transfer issues. Conduct investigations and design experiments to identify root causes of production problems.
- Produce comprehensive technical reports (i.e., CAPA's).
- Establish and maintain lines of communication to ensure timely and accurate flow of information. The incumbent will regularly interact with counterparts, including but not limited to, Engineering, Manufacturing, QA, Production Planning, Purchasing, Accounting, and R&D.
- Familiar with all current manufacturing processes, procedures, and policies. Draft and revise documents including SOP's, MRP's, specs, and QTP's.
- Maintain records of laboratory activities and notebooks in a professional, accurate manner. Maintain records as per QSR and ISO guidelines.
- Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has an awareness of device defects that may arise in their area of responsibility, including product design, verification, and validation, manufacturing, and testing activities
- 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; build productive internal/external working relationships
- Carries out duties in compliance with established business policies
- Other duties as assigned, according to the changing needs of the business
EDUCATION AND EXPERIENCE YOU'LL BRING
Required
- Bachelors Degree in a scientific field (for example, Chemistry, Biology, Biochemistry, or other Biological Sciences)
- Laboratory Experience: demonstrated skills in carrying out laboratory/research assignments with minimal guidance in an accurate, effective manner.
Preferred
- MA/MS in Chemistry or Biological Sciences
- Knowledgeable of federal and other regulations, e.g. QSR's, ISO, ISO 13485, CMDR
- Knowledge off GMP
- Knowledge of QMS
- Experience with Verification & Validation
- Experience with process documentation
- Exposure to the manufacturing environment
- Strong verbal and written communication skills
- Organized and detail-oriented
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
- A fast-paced work environment where your safety is our priority
- Production areas that are clean, well-lit, and temperature-controlled
- Training and career development, with onboarding programs for new employees and tuition assistance
- Financial security through competitive compensation, incentives, and retirement plans
- Health care and well-being programs including medical, dental, vision, wellness, and occupational health programs
- Paid time off
- 401(k) retirement savings with a generous company match
- The stability of a company with a record of strong financial performance and a history of being actively involved in local communities