QC Applications & Data Specialist

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,…