QC Applications Specialist

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 122000 colleagues serve people in more than 160 countries.

Position Overview:

The QC Applications 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 companys 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 companys 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:

• Bachelors degree in Analytical or Applied Chemistry Molecular Biology Biochemistry or related field is required plus a minimum of 4 years experience in biotechnology; or Masters 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

$61300.00 $122700.00

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

Quality Assurance

ONCO Cancer Diagnostics

United States > Madison : 650 Forward Dr

Standard

No

Not Applicable

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: EEO is the Law link - Espanol: Experience:

IC