Sr. Associate Scientist II, Technical Support
Summary of Major Responsibilities
The Sr. Associate Scientist II, Technical & Product Support role will lead and assist in 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 supporting Production and Quality Control 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 and Quality teams.
- Lead and support troubleshooting of Out Of Specifications (OOS), non-conformances (NCMs), and corrective action preventive action (CAPA) plans through root cause investigation, experiment design, study execution, data analysis and reporting.
- Provide technical support to Supply Chain team and key suppliers for sourced materials.
- Analyze, track, and trend historical Production and Quality Control data.
- Lead and assist in training and transfer of processes and/or procedures as part of corrective action implementation.
- Clearly and accurately generate experimental protocols, draft work instruction procedures, characterize Test Methods, and summarize activities through technical summary or investigative reports.
- Program and operate complex instrumentation such as micro plate readers, Real-Time PCR instruments, and liquid handling automation.
- Conduct bench level experiments within several product or technology areas to identify problems and discrepancies.
- Support and comply with the company’s Quality Management System policies and procedures.
- Performs other related duties and special projects as assigned by management.
- Proficient in a variety of common laboratory skills and techniques with a base knowledge in Chemistry, Biochemistry, Molecular Biology, or a related field.
- Strong understanding of IVD product Manufacturing processes, Biochemical, Molecular & Real-Time-PCR Assays.
- 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 frequent changing priorities.
- Effective analytical, problem solving and decision making skills. Proven ability to work effectively in team situations as well as independently. Able to collaborate across functions and within a workgroup to meet business objectives.
- Excellent oral and written, communication, interpersonal, 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.
- Knowledge and experience working within a CFR 820, ISO 13485, ISO 12207 and/or cGMP structured environment.
- Ability to travel as needed.
Preferred Qualifications (optional)
- > 4 years’ experience with Medical Device Products in a Technical or Product Support role.
- 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).
- Experience with Project Management principles and practice.
Education and Experience
- Bachelor’s degree in Life Sciences, or related field plus a minimum of 7 years’ experience, or Master’s degree in a Life Sciences field plus at least 3-4 year of industry experience.
- Extensive hands-on experience in molecular biology and biochemical techniques.
- Advanced knowledge of statistical and mathematical methods in biology/genetics, including experience with JMP software.
- Ability to use computers daily in an interactive manner for extended periods of time.
- Ability to sit for an extended period of time.
- Ability to frequently and accurately communicate with employees in person, via the telephone or by email.
- Ability to work with blood, tissue, stool or other human specimen samples.
- Ability to lift and move up to 40 pounds on an occasional basis.
Exact Sciences is 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. The Company’s affirmative action program is available to any applicant or employee for inspection upon request.
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