8 days old

Technical Support Scientist

Kelly Services
Santa Ana, CA 92702
**Technical Support Scientist in Irvine, CA**

This position receives and processes customer inquiries and complaints and will document and convey this information to the appropriate functional department for resolution. In addition, the TSS will lead the activities related to resolving complaints, assessing corrective action, and corrective action preventive action (CAPA).


+ Determine the nature of direct and indirect customer inquiries, and classify them for resolution

+ Serve as a resource for R&D and commercial groups to support product evaluations by keeping the focus on technical resolution with in-house groups

+ Assist in process improvement projects to improve effectiveness and efficiency of process directly affecting our customers and their adaptation of our products

+ Analyze product evaluations for performance and technical trends to enhance our technical response to issues and to realize opportunities

+ Manage and monitor customer inquiries associated with complaints

+ Manage and coordinate cross-functional activities for corrective/preventive action program

+ Ensure timely closure of customer complaints and that established turnaround times are met

+ Ensure processes and procedures comply with applicable standards related to complaints

+ Provide technical support, as needed, for the preparation of regulatory submissions for FDA/EU/CMDR or other regulatory agencies

+ Assist with changes to product design, specification or production processes and review risk analysis files as required

+ Assist in the communication with regulatory agencies, notified body, and competent authorities as associated with complaints

+ Develop materials (e.g. FAQs) to reduce the number of recurring inquiries on products

**Experience/ Education:**

+ MS in Life Science field or equivalent

+ 2 or more years of experience in technical customer support preferred

+ 2 or more years of experience in Cell Therapy and/or Gene Therapy.

+ 2 or more years of experience in cell biology and/or tissue culture

+ 2 or more years of experience in Assisted Reproductive Technology or Cytogenetics

+ Knowledge of GMPs, CFRs, USP, ISO 13485, CMDR, MDD 93/42/EEC, IVD D 98/79/EC, ISO harmonized standards (EN14971, EN 13408, EN 13824) preferred

+ Knowledge of quality control methodology, QA control systems and production methodologies preferred

+ Ability to obtain cooperation from other groups and lead cross functional teams

+ Experience with risk management and Failure Mode Effects Analysis (FMEA) preferred

+ Strong root cause analysis skills required

+ Proficient in Microsoft Word, Excel, PowerPoint, Outlook

**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

**Why Kelly** **** **?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (
Posted: 2021-11-19 Expires: 2021-12-20

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Technical Support Scientist

Kelly Services
Santa Ana, CA 92702

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