QC Applications & Data Specialist

Regulatory Jobs; Madison (WI); Presencial; USD 61.000 - 123.000; Jornada completa

Descripción de la vacante

Abbott in Madison, WI, seeks a QC Applications & Data Specialist to lead quality control automation, data trending, and analysis workbooks. The role includes protocol development, validation, and documentation aligned with cGMP/GLP guidelines.

The ideal candidate brings SAS JMP experience, scripting skills, and strong data interpretation abilities, with travel up to 10% regionally and 5% off-site.

Formación

• Bachelor’s degree in Analytical or Applied Chemistry, Molecular Biology, Biochemistry or related field is required, plus 4+ years in biotech.
• 1+ years of experience with SAS JMP or similar statistical software for data trending and evaluation.
• 1+ years of coding and scripting within software and statistical applications.
• 2+ years in GMP/ISO13485 lab environment with strong documentation.
• Proficient in MS Office and Excel.

Responsabilidades

• Lead and participate in QC applications and automation projects as described.
• Develop, validate, and implement QC Analysis Workbooks for data evaluation.
• Draft and review quality documents (SOPs, Test Methods) compliant with cGMP/GLP.
• Support CAPA and deviation reporting related to QC applications.
• Travel up to 10% between local Madison locations and 5% away as needed.

Conocimientos

SAS JMP

Data trending

Statistical software

JSL coding

Educación

Bachelor’s degree in Analytical/Applied Chemistry, Molecular Biology, Biochemistry or related field

Master’s degree or Ph.D. in Life Sciences or Mathematics or related field

Herramientas

JMP Script Language (JSL)

Excel

Microsoft Office

Descripción del empleo

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.

JOB DESCRIPTION:

Position Overview:

The QC Applications & Data Specialist will lead and/or participate in a variety of Quality Control functions relating to the automation and applications in use, including but not limited to, the Electronic Form Database (EFD), Data Trending, QC Analysis workbooks, Liquid Handling Automation Method Scripts, and quality documentation generation. The position is responsible for implementation, tracking, trending, and reporting on these processes.

Essential Duties:

Include but are not limited to the following:

• Support of EFD processes, form development, and expansion for Quality Control. Subject Matter Expert in new, or updates to, test method EFD forms and their implementation.
• Leads or supports project activities associated with Quality Control Applications and Automation, which may include leading the creation and/or implementation of liquid handling method scripts.
• Utilize basic knowledge of statistics and interpretation of analyses to draw conclusions from data summaries.
• Support or lead the development, validation, implementation, and improvements of test method specific QC Analysis Workbooks for data evaluation and disposition using SAS JMP Statistical Software, or similar software.
• Participates in Deviation report generation and CAPA efforts pertaining to QC Applications used.
• Lead and/or mentor individuals to complete essential tasks relating to the QC applications and automation.
• Draft and execute protocols for quality system software or analysis workbook Validation efforts in accordance with internal procedures, cGMPs, FDA, and ICH guidelines.
• Write, update, and review of quality documents, including but not limited to, Standard Operating Procedures and Test Methods that are compliant with cGMP/GLP guidelines.
• Provide support in cross functional teams, as required.
• Support and comply with the company's safety and environmental procedures.
• Support the Operations department in other non-laboratory functions, as determined by Operations management.
• Perform other related duties as assigned by management.
• 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.
• Ability to develop and follow procedures or experimental plans.
• Ability to interface and work effectively within team and department, as well as all levels of the organization, vendors, customers, etc.
• Ability to effectively work on many complex and varied projects at one time, with frequent changing priorities.
• Ability to act with an inclusion mindset and model these behaviors for the organization.
• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 100% of a typical working day.
• Ability to work on a computer and phone simultaneously.
• Ability to use a telephone through a headset.
• Ability to lift up to 40 pounds.
• 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 and means to travel 10% between local Madison, WI locations.
• Ability to travel 5 % of working time away from work location, may include overnight/weekend travel.

Minimum Qualifications:

• Bachelor’s degree in Analytical or Applied Chemistry, Molecular Biology, Biochemistry or related field is required, plus a minimum of 4 years’ experience in biotechnology; or Master’s degree or Ph.D. in Life Sciences, Mathematics, or related field plus a minimum of 2 years’ experience in biotechnology; Equivalent combination of education and experience may be considered.
• 1+ years of experience in SAS JMP or others statistical software for data trending, calculation, and evaluation.
• 1+ years of coding and scripting within software and statistical applications.
• 2+ years of experience in a GMP/ ISO13485 laboratory environment and strong documentation skills in accordance with GMP requirements.
• Strong working knowledge in using basic software applications including Microsoft Office and Excel.
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
• Authorization to work in the United States without sponsorship.

Preferred Qualifications:

• Experience in JMP Script Language (JSL) coding within SAS JMP Statistical Software.
• Experience in complex molecular biology or analytical chemistry techniques in a Quality Control setting.
• Experience with Project Management principles and practice.

The base pay for this position is

$61,300.00 – $122,700.00

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Quality Assurance

DIVISION:

ONCO Cancer Diagnostics

LOCATION:

United States > Madison : 650 Forward Dr

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

No

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

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.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf