Associate Product Support Scientist

Abbott; Madison (WI); On-site; USD 70,000 - 90,000; Full time

Job summary

Abbott is seeking an Associate Product Support Scientist based in Madison, WI. The role collaborates with Production, QC, Supply Chain, R&D, and Quality teams to provide technical support and drive continuous improvement within Operations.

The position involves root-cause analysis, CAPA, and supporting PCR/NGS-based reagents and products, with opportunities to qualify new materials and optimize processes in a fast-paced manufacturing environment.

Qualifications

• Basic knowledge base in molecular biology, biochemistry, biotechnology, chemistry, or related field.
• Experience with investigations of Out of Specification (OOS), non-conformances (NCMRs), and CAPA plans is beneficial.
• Experience supporting PCR-based and/or NGS-based reagents and products is advantageous.

Responsibilities

• Provide technical and product support to Operations across Production, QC, Supply Chain, R&D, and Quality teams.
• Perform investigative testing for OOS, NCMRs, and CAPA plans through root cause investigation and data analysis.
• Support PCR-based and/or NGS-based reagents and products in manufacturing and quality contexts.
• Collaborate with cross-functional teams to qualify new raw materials and alternative supply channels.

Skills

Root cause analysis

Technical support

Cross-functional collaboration

Data analysis

Communication skills

Education

Bachelor's degree in Life Sciences

Tools

PCR Instruments

NGS Platforms

Laboratory Automation

Job description

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 122,000 colleagues serve people in more than 160 countries.

The Associate Product Support Scientist role will support and assist in a variety of technical support activities within Operations. This position will investigate issues through root cause analysis and implement correction actions through use of the Quality Management System supporting Production and Quality Control groups through continuous improvement.

Location : Onsite - Position is based in Madison, WI

Hours: 1st shift, 8am-4:30pm

Essential Duties
Include, but are not limited to, the following:

• Provide technical and product support to Operations working cross-functionally with the Production, QC, Supply Chain, R&D, and Quality teams.
• Perform investigative testing for Out of Specification events (OOS), non-conformances (NCMRs), and corrective action preventive action (CAPA) plans through root cause investigation, experiment design, study execution, data analysis, and reporting.
• Provide support for PCR-based and/or NGS-based reagents and products.
• Provide support to Operations teams for qualifying new raw materials and alternative supply channels for products.
• Demonstrated proficiency in a variety of basic laboratory skills and techniques.
• Basic knowledge base in Molecular Biology, Biochemistry, Biotechnology, Chemistry, or a related field.
• Good understanding of in-vitro diagnostic product manufacturing processes and relevant assays (e.g. biochemical, RT-PCR, and NGS).
• Program, operate, and troubleshoot complex instrumentation such as microplate readers, real-time and digital polymerase chain reaction (PCR) instruments, next-generation sequencers, and liquid handling automation.
• Assist development and characterization of simple manufacturing processes incorporating industry standard techniques.
• Assist characterization of basic assay variability for simple measurement systems.
• Apply basic statistical techniques: assessing data normality, control charting and data trending, hypothesis testing, assessing variation, linear regression and model fitting.
• Analyze data to identify trends, assists troubleshooting and root cause investigation efforts with ability to utilize recognized root cause analysis tools.
• Assist investigations into analytical and functional assays, associated equipment, materials, and/or processes.
• Clearly and accurately generate experimental protocols, draft work instruction procedures, test methods, and summarize development activities through technical summary reports.
• Support Process and Test Method Validation readiness and execution. Provide support and review in generating Validation documentation.
• Write new and edit existing Quality System documents (e.g. work instructions, standard operating procedures). Responsible for generating/driving corrective actions/action plans for changes.
• Collaborate with other departments (Quality Engineering, R&D, Regulatory Affairs, Supply Chain, Production, Validation, Quality Control) to achieve business results. Able to meet objectives without negatively impacting other functions.
• Actively participates in project execution.
• Consistently hit deliverables as outlined by manager.
• Function independently with limited guidance from supervisor as well as part of a team. Adaptable to rapid changes in priorities, strong sense of urgency, and able to identify ways to work together to achieve results needed for all requests.
• Strong verbal and written communication skills.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• Support and comply with the company's Quality Management System policies and procedures.
• Maintain regular and reliable attendance.
• Ability to act with an inclusion mindset and model these behaviors for the organization.
• Ability to work designated schedule.
• Ability to work nights and/or weekends, as needed.
• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 80% of a typical working day.
• Ability to work on a computer and phone simultaneously.
• Ability to use a telephone through a headset.
• Ability to work seated for approximately 80% of a typical working day. Ability to work standing for approximately 20% of a typical working day.
• Ability to lift up to 40 pounds on an occasional basis.
• Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height.
• Ability to comply with any applicable personal protective equipment requirements.
• Ability to use various types of laboratory equipment; including microscopes, microtomes, blades, strainers, and pipettes for extended periods of time.