ABBOTT LABORATORIES Assay Integration Salary in the United States

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 103,000 colleagues serve people in more than 160 countries.

Job Summary:

• Defines and documents critical sub-system performance requirements that link to system design across interacting functions. (i.e., hardware, software,labeling and/or assay)
• Identifies, confirms and interprets interacting cause & effects behind instrument issues, discrepancies, problems or complaints in accordance with governing procedures.
• Devises root cause hypotheses and confirms instrument issues, discrepancies, problems or complaints in accordance with governing procedures.
• Develops or provides input into complex project plans and timelines.
• Develops and executes system related (i.e., hardware, software,labeling and/or assay) verification & validation and/or characterization protocols and develops and interprets complex written data package summaries in accordance with governing procedures.
• Defines investigative paths for and confirms Complaint Handling investigations to closure.
• Application of advanced Risk Management techniques to a non-conforming product, regulatory or customer notifications. Develops product Risk Analysis.

Main Responsibilities:

• Writes and executes complex system related (i.e., hardware, software,labeling and/or assays) verification and/or characterization protocols including acceptance criteria, analyzes data, write data summaries in accordance with governing procedures.
• Advanced troubleshooting of customer complaints in accordance with governing procedures.
• Advanced troubleshooting across all system & assay functions (hardware and software or hardware and assay performance problems).
• Advanced proficiency in the assay applications, operation of instrument, software operating systems, and repair/replacement of parts/sub-assemblies.
• Responsible for developing departmental/site procedures.
• Responsible for implementing and maintaining the effectiveness of the ADD quality system.
• Applies quantitative methods, analyzes data, evaluates results, forms conclusions and provides/implements improvements.

Accountability/Scope:

• Receives little detailed or general direction; exercises considerable discretion as to personal work details as well as the work details of other technical personnel.
• Creates and reviews project timelines and task sets; recommends resource allocations against project plans and timelines and impact of project scope changes..
• Reviews, generates and approves related inputs such as protocols and plans.
• Devises or recommend s changes to departmental and/or site level procedures that interpret the intent of the QSR.

Qualifications:

• Bachelors degree in Life Science or closely related discipline is necessary.
• Masters or higher degree is desired. · 6-10 years work related experience.  
• Knowledge of external regulations and standards affecting IVDs and Biologics.
• Reviews and approves Verification or Characterization related inputs.
• Good Lab Practice, PC Skills (Word, Excel, Powerpoint); Data representation
• Reviews, generates and documents Verification & Validation or characterization related inputs.
• Demonstrates use of statistics, Design of Experimentation, Six Sigma method, FEMA Cause and Effect or Fishbone Diagram, DOORS, Excel, Powerpoint, Word. ID Critical Performance Requirements Based on Customer Needs (QFD, bench marking)
• Optimizes processes: set targets, ranges and specs - DOE, Guard band, Tolerance analysis, Capability (CPk), Test Method development, determine manufacturability / FPA.
• Presents, delivers and interprets information amongst senior team members, scientists, engineers, and other systems development personnel across sites and companies.
• Advanced knowledge of external regulations and standards affecting IVDs and Biologics.
• Can represent complex technical findings in succinct non-technical formats
• Proficient in operation of instruments, and repair/replacement of parts/subassemblies.
• Proficient in complex Project management.