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

Essential Duties

Include but are not limited to the following:

• Provide technical and product support to Operations by working cross-functionally with the Production, QC, Supply Chain, R&D and Quality teams.
• Perform investigative testing for Out of Specification (OOS) results, non-conformance (NCMR) events, and corrective action preventive action (CAPA) plans.
• Support high-risk material assessments to identify mitigating actions.
• Perform alternative supply qualification testing.
• Participates in pFMEAs, analyzes data to identify trends, assists troubleshooting and root cause investigation efforts.
• Support the development, training, and transfer of processes and/or procedures into Operations.
• Support Process and Test Method Validation readiness and execution.
• Generate experimental protocols and document completed activities clearly and accurately through technical summary reports under general supervision.
• Able to develop and characterize formulation processes for simple buffers or mixtures.
• Provide technical support for NGS based reagents and products.
• Program and operate complex instrumentation such as microplate readers, real-time polymerase chain reaction (PCR) instruments, next-generation sequencers, and analytical instruments; including, but not limited to, high performance liquid chromatography (HPLC), automated titrators, densitometers, spectrophotometers, and liquid handling automation.
• Troubleshoot automated liquid handling instrumentation, detection equipment, functional assays, and analytical methods.
• Support development and validation of automated liquid handling instrumentation and methods.
• Ability to effectively communicate with multi-level personnel as well as outside vendors and their representatives.
• Effective analytical, problem solving, and decision-making skills.
• Ability to work effectively independently and in team situations.
• Excellent oral and written communication, interpersonal, collaboration and presentation skills.
• Strong attention to detail.
• Ability to prioritize tasks and adhere to project schedules and timelines.
• Ability to thrive in a fast-paced, frequently changing, and evolving environment.
• 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 lift up to 40 pounds on an occasional basis.
• 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 comply with any applicable personal protective equipment requirements.
• Ability to use various types of laboratory equipment including pipettes for extended periods of time.
• May be exposed to hazardous materials, tissue specimens and instruments with moving parts, lasers, heating and freezing elements, and high-speed centrifugation.
• Ability and means to travel between Madison locations.
• Ability to travel 5% of working time away from work location, may include overnight/weekend travel.

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Minimum Qualifications

• Bachelor’s degree in life sciences or related field as outlined in the essential duties.
• 2+ years of biotechnology industry experience.
• 2+ years of experience with medical device products in a product development or product support role.
• 2+ years working within an FDA regulated 21 CFR 820 environment, ISO 13485, ISO 12207, and/or cGMP structured environment.
• 2+ years of experience with in vitro diagnostic (IVD) product manufacturing processes, biochemical, molecular, and/or real-time-PCR assays, and/or analytical assays.
• Proficient in a variety of common laboratory skills and techniques with base knowledge in chemistry, biochemistry, and/or molecular biology.
• Coursework or proficient working knowledge of statistical and mathematical methods; including, but not limited to, proficiency in JMP statistical analysis software.
• Proficient in Microsoft Office.
• 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

• 2+ years of experience with project management principles and practice.
• Professional working knowledge of design of experiments (DOE), measurement system analysis (MSA), characterization study design, and hypothesis testing.
• Understand and apply basic continuous improvement methodologies and principles.
• 1+ years of experience with next-generation sequencing technology.

Salary Range:

$56,000.00 - $89,000.00
The annual base salary shown is for this position located in US - WI - Madison on a full-time basis. In addition, this position is bonus eligible, and is eligible to receive company stock upon hire as well as annually. Benefits offered include a retirement savings plan, paid vacation, holiday and personal days, paid caregiver/parental leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms, conditions, and eligibility requirements of the applicable plans.If you require a reasonable accommodation with the application process, please email

hr@exactsciences.com

.

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.

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