Projects Implementation Associate

Abbott Laboratories•Santa Rosa, CA

12h

About The Position

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. Projects Implementation Associate 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. 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 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 The position of Projects Implementation Associate is within our Toxicology business unit located in Santa Rosa, CA. The main purpose of the position is to establish and maintain effective structures to ensure consistent implementation of quality systems at the Santa Rosa lab. The Implementation associate is responsible for creating processes and process improvements to ensure consistent implementation of internal requirements and external Laws, Regulations, Guidance, and Standards (LRGS). This role requires a dynamic and self-motivated professional with strong collaboration skills and demonstrated ability to execute change. Strong technical writing is a key requirement of the role. This role will be instrumental in driving quality improvements to enhance our value proposition to our clients.

Requirements

Bachelor’s degree in chemistry, Biology or a related scientific discipline, or an equivalent combination of education and experience
Minimum 5 years’ experience working in a clinical or forensic testing laboratory with at least 3 years working with LC/MS/MS or GC/MS
Working knowledge of the Clinical Laboratory Improvement Amendments (CLIA '88) and College of American Pathologists accreditation requirements
Strong ability to interpret regulatory requirements and to translate them into clear, practical and actionable processes.
Effective communication through excellent written and verbal communication skills, and strong interpersonal skills.
Strong work ethic to drive for timely results with unwavering commitment to safety, compliance, and quality.
Highly organized and attentive to detail, with ability to work collaboratively on multiple tasks both individually and as part of a team.

Nice To Haves

Experience developing and writing policy manuals and procedure documents
Experience working in a CAP or SAMHSA accredited laboratory
Experience performing method/instrument validations/verification studies

Responsibilities

Identify internal requirements and external laws, regulations, guidance and standards (LRGS) applicable to the lab’s quality systems.
Interpret applicable internal requirements and external LRGS and incorporate them into requirements for use in the lab’s business processes.
Identify areas of potential noncompliance within the lab.
Review and update the Quality System Manual as needed.
Collect business process data from different parts of the company for analysis.
Act as an expert resource in specific LRGS requirement knowledge for the lab.
Identify training requirements, programs, and tracking systems.
Cultivates a wide range of internal networks and begins to develop an external network of resources to facilitate completion of tasks.
Plan, organize, and prioritize daily work routine to meet established project schedule.
Complete project assignments in a timely, accurate manner and accomplish tasks as required with little or no supervision.
Interact effectively with all levels of the organization and perform multiple tasks in a fast-paced environment.
Work with groups within the organization to get corrections, clarifications, and updates to Quality Documents finalized and implemented.
Support Document Control Activities including document review and change orders, as required.
Train and mentor other lab personnel in the operation of analytical systems, work processes, and regulatory requirements in line with established procedures.
Actively participate in and assist with internal and external audits.
Demonstrate commitment to the development, implementation and effectiveness of Quality Management System to meet regulatory standards.
Provide continual evaluation of processes and procedures to identify gaps and suggest ways to improve compliance, quality, and efficiency.
Support method and equipment validation/verification testing through analysis, data review, and report writing as needed.
Perform additional duties and projects assigned.

Benefits

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 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.

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