11 days old

Quality Control (QC) Scientist

Kelly Services
Mountain View, CA 94035
**QC Scientist Mountain View, CA**

QC Scientist will be a member of the HCATS Quality Control Department. As a Senior Member of the team she or he will be involved in various QC projects and should have a deep understanding of general QC flow and the Product Cycle.

**Essential Functions and Responsibilities**

+ Support internal and external customers to ensure that proper and timely execution of all aspects of the clinical analytical method life cycle across HCATS clients.

+ Support routine GMP testing as assigned. Mentor and train team members

+ Evaluate corporate and regulatory requirements along with coordination of activities for implementation of these requirements.

+ Write the contents of Analytical Method Transfer and Validation life cycle documentation including master plans, protocols, test methods, and reports.

+ Create validation project plan i.e., timelines and resources and provides status updates to management.

+ Utilize statistical tools for evaluation of method validation and trending data.

+ Identify, evaluate, and implement continuous business process improvements.

+ Perform troubleshooting activities with respect to methods/assays, equipment malfunctions and investigations Deviations and OOS.

+ Provide support during laboratory investigations. Provide support during equipment qualification.

+ Train QC personnel during method transfer and validation.

+ Consistently produce elevated level of documentation accuracy and clarity according to cGMP documentation practices.

+ Ability to set deadlines and prioritize work for self, group members, and support groups involved.

+ Ability to review/approve work performed by coworkers for accuracy and alignment with procedures.


+ B.S in Analytical Chemistry or other scientific field with 8-10 years of experience in the areas of method development, validation, and transfer; or MS/Ph.D. in Analytical Chemistry or other scientific field with demonstrated experience in Quality Control laboratories for biotechnology products.

+ Strong background and in-depth knowledge in analytical chemistry e.g. Flow Cytometry, ELISA, HPLC, CE, PCR, etc.

+ Must have extensive knowledge and experience of QC assay development, transfer, and validation, along with cGMPs.

+ Excellent communication skills, both written and verbal, with all levels of the organization,

+ Ability to create and manage work plans and timelines and independently manage competing priorities with limited instruction.

+ Must be familiar with GMP lab environment and Aseptic techniques.

**For immediate consideration, apply today! Contact Toni for further information at 714 454 8252 OR**

**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. 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: 2021-02-17 Expires: 2021-03-20

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Quality Control (QC) Scientist

Kelly Services
Mountain View, CA 94035

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