The Production Associate II will lead or assist in a variety of Production functions.  Functions include simple and complex buffer formulations using chemistry laboratory equipment, label printing, bulk reagent production and dispensing, and kitting of finished goods. The position will work within defined protocols and procedures and may develop and document new procedures for Production. This role is expected to independently follow detailed instructions and specific procedures with periodic direct supervision.

This is a permanent, full time position working M-F during 1^st shift hours.

• Participate in or lead simple and complex buffer preparation, Automated Fill / Cap / Label, label printing, and kitting of finished goods.  Participate in Capture Bead manufacture. 
• Mentor and develop junior level Production associates via operator training/certification programs, acting as a certified trainer.
• Assist in developing, transferring, scaling and validating manufacturing processes, in accordance with company procedures, cGMPs, FDA, and ISO 13485 guidelines.
• Assist or lead process improvement efforts, through the Change Request / Change Order process, or via other means.
• Generate Nonconforming Material Reports, Change Orders, Change Requests, Out of Specifications, Investigations, and Corrective Actions including any deliverables associated with these items. 
• Manage inventory via KANBAN system for raw materials, intermediates, disposables and spare parts related to the Production areas.
• Assist with continuous improvement projects and support other areas needs dependent on demand.
• Strong communication skills and ability to coordinate work with other teams.
• Ability to follow written procedures with minimal direction.
• Demonstrates a basic theoretical understanding of the work tasks assigned.
• Ability to complete assignments in expected time frames and independently seek out additional work with tasks are completed ahead of time.
• Ability to be involved with trouble shooting and problem solving to learn possible solutions and problems.
• 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.
• Regular and reliable attendance.
• Ability to work designated schedule.
• Ability to work nights and/or weekends.
• Ability to work overtime as needed.
• Ability to lift up to 40 pounds for approximately 25% of a typical working day.
• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
• Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height.
• Ability to work on a computer and phone simultaneously.
• Ability to use a telephone through a headset.
• Ability to comply with any applicable personal protective equipment requirements.
• Ability to utilize lab equipment and moving machinery for extended periods of time (includes pipetting, traying robots etc.).
• Ability to use and wear safety protective gear/equipment (e.g. safety glasses, lab coat, gloves, beard nets, hair nets, booties, hearing protection, etc.) and follow safety guidelines while in the lab etc., for extended periods of time.
• Ability to work at a laboratory bench or fume hood for extended periods of time.
• Ability to work with skin irritants, lung irritants, electrical equipment, sharp instruments, toxic materials, and hazardous waste.
• Ability to work in front of a computer screen and/or perform typing for approximately 50% of a typical working day.
• Constant walking or motion to coordinate work and interact with employees.
• Ability to perform fine manipulation and simple grasping using hands for extended periods of time.
• Ability and means to travel between Madison locations.
• Ability to travel 5% of working time away from work location, may include overnight/weekend travel.

Minimum Qualifications

• Associate’s degree in life sciences or related field; or high school degree/general education diploma and 2 years of relevant experience in lieu of degree.
• 1+ years of experience working in a relevant manufacturing setting.
• Basic computer skills and usage of software applications including Microsoft Office.
• Strong documentation skills and attention to detail necessary in a GMP environment.
• Ability to understand and independently apply GMPs to everyday work regarding documentation and instrument use.
• Authorization to work in the United States without sponsorship.
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

Preferred Qualifications

• Bachelor’s degree in life sciences or related field.
• Experience in a biotech manufacturing environment, preferably in a GMP and/or ISO 13485 environment.

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We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.