|Date Posted||June 22, 2021|
|Address||441 Charmany Drive|
Summary of Major Responsibilities
The Senior Associate Scientist II, Product Support role will lead a variety of technical support activities within Operations. This position will investigate issues through root cause analysis and design and implement corrective actions through use of the Quality Management System (QMS) supporting Production, Quality Control, and Supply Chain groups in continuous improvement.
Essential Duties and Responsibilities
- Provide technical and product support to Operations by working cross-functionally with the Production, QC, Supply Chain, R&D, Clinical Laboratory, and Quality teams.
- Lead and support troubleshooting of out of specification (OOS), nonconformance reports (NCMRs), and corrective action and preventive action (CAPA) plans through root cause investigation, experiment design, study execution, data analysis, and reporting.
- Provide technical support to the Supply Chain team and key suppliers for sourced materials and perform technical evaluations of alternatively sourced materials.
- Analyze, track, and trend historical production and quality control data.
- Lead and assist in the training and transfer of processes and/or procedures, as part of corrective action implementation.
- Generate clear and accurate experimental protocols, draft work instruction procedures, characterize and assist in transfer of Test Methods, and summarize activities through technical summary or investigative reports.
- Program, operate, and troubleshoot complex instrumentation, such as micro plate readers, real-time PCR instruments, and liquid handling automation.
- Assist with design and execution of complex studies and designed experiments.
- Conduct bench level experiments within several product or technology areas to identify problems and discrepancies.
- Apply knowledge of working within an FDA regulated 21 CFR 820 environment, ISO 13485, and/or cGMP structured environment.
- Support and comply with the company’s Quality Management System policies and procedures.
- Ability to effectively communicate with multi-level personnel, as well as outside vendors and their representatives.
- Ability to effectively work on several varied projects at one time, with frequently changing priorities.
- Apply effective analytical, problem solving, and decision-making skills; ability to work effectively in team situations, as well as independently.
- Exercise excellent oral and written communication, interpersonal, and presentation skills; ability to collaborate across functions and within a workgroup to meet business objectives.
- Apply 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.
- Maintain regular and reliable attendance.
- Ability to work designated schedule, generally standard business hours, Monday-Friday.
- Ability to occasionally work nights and/or weekends.
- Ability to lift up to 50 pounds for approximately 5% of a typical working day.
- Ability to utilize lab equipment for approximately 75% 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 60% 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 comply with any applicable personal protective equipment requirements.
- Ability to work with blood, tissue, stool, or other human specimen samples.
- Ability and means to frequently travel between Madison locations.
- Ability to travel 5% of working time away from work location, may include overnight/weekend travel.
- Bachelor’s Degree in the Life Sciences or related field.
- 7+ years of biotechnology industry experience.
- 4+ years of experience with medical device products in a Product Development or Product Support role.
- 4+ years working within an FDA regulated 21 CFR 820 environment, ISO 13485, ISO 12207, and/or cGMP structured environment.
- 4+ years of experience with IVD product manufacturing processes, biochemical, molecular, and real-time-PCR assays, and/or analytical assays.
- Coursework or proficient working knowledge of statistical and mathematical methods; including proficiency in JMP software.
- Demonstrated ability to apply common laboratory skills and techniques; including a base knowledge in chemistry, biochemistry, molecular biology, or a related field.
- Authorization to work in the United States without sponsorship.
- Demonstrated ability to perform the essential duties of the position with or without accommodation.
- Master’s degree in the Life Sciences or related field.
- 2+ years of experience with medical device products in a technical or product support role.
- 2+ years of experience with project management principles and practice.
- Strong knowledge in design for Six Sigma and statistics.
- Strong knowledge in basic and advanced continuous improvement methodologies/ principles, such as LEAN Six Sigma and/or Practical Process Improvements (PPI).