Senior Quality and Assay Development Specialist - Military Veterans
at Kelly
Kelly® Science & Clinical is seeking a Senior Quality Specialist for a one-year contract opportunity with a leading molecular diagnostics company at their headquarters in Sunnyvale, CA. If you are driven by the prospect of translating cutting-edge scientific discoveries into tangible advancements and are poised to advance your career, join us as we pioneer progress in the biotechnology realm.
Workplace: Onsite in Sunnyvale, CA
Position Title: Senior Quality Specialist
Position Type: One-year contract
Pay rate: $64-84/ hour.
Company: Kelly® Science & Clinical
Overview
The Senior Quality Specialist is responsible for supporting quality systems activities related to assay development, especially, design control and risk management activities in accordance with FDA and ISO regulations. This position is part of the Product Lifecyle Quality group in R&D and reports to the Sr. Manager, Product Lifecyle Quality and will be onsite based, located in Sunnyvale, California.
Responsibilities
- Participate as Quality representative on select product development teams which includes providing guidance for Market Specification, Functional Specification, Design Verification, Design Validation, Test Method Validation, Risk Assessments, and Design Reviews; and provide guidance and decisions on product development activities to ensure continued compliance with internal procedures and applicable ISO and FDA standards.
- Provide design control guidance to junior NPI Quality specialists and provide technical oversight of product shelf-life/stability program.
- Fulfill all quality planning, stability, and risk management deliverables with feedback from cross-functional teams.
- Ensure required documentation is completed prior to new product launch, and coach product development teams to successful completion where necessary.
- Provide technical expertise for post market investigations and design changes, including documentation of investigations following standard out of specification SOPs and assessment of changes using design control methods.
Qualifications
- B.S. degree with 5+ years of related experience or M.S. degree with 3+ years of related experience, degree in Chemistry, Biology, or related physical or biological science field.
- Related work experience in Quality with a focus on assay development in a medical devices or pharmaceutical industry with applicable knowledge of cGMP, ISO, and FDA regulations.
- Experience in implementing design control and risk management activities.
- Experience with technical data and capable of making risk-based recommendations, taking into account broad perspectives that support both the regulations and the business.
- Adept with Microsoft Word, Excel, Visio, PowerPoint, and Minitab.
Preferred:
Quality Systems/Quality Engineering background in molecular biology products or molecular diagnostic products utilizing PCR
Why Join Us:
- Competitive compensation package and potential for permanent placement following the temporary period.
- Opportunity to work at the forefront of biotechnology innovation in a collaborative and dynamic environment.
- Access to ongoing career development and networking opportunities through Kelly® Science & Clinical's expansive network of industry experts and recruiters.
If your qualifications align with the requirements of this role, we invite you to apply and take the next step in your career journey. Rest assured, even if this opportunity isn't the perfect match, your profile will remain within our network, ensuring you're connected to a wealth of future opportunities in the field of science and clinical research.
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As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.About Kelly
Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center.
Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Sunnyvale, CA
Why Kelly - Since 2011 we have placed over 16,000 Veterans
Need More?
Kelly applies targeted recruiting initiatives to the Veterans population (in all stages of transition) by aligning customer defined requirements with military skills and experience. The transition from military to civilian life can be stressful and complex for veterans, and our staff is trained to assist in this transition. Unlike our competition, Kelly places these resources without geographic or industry constraints, offering our customers and our employees greater flexibility. Kelly has a wide variety of local opportunities, for Veterans and their spouses, within our workforce solutions as well as national recruiting programs on behalf of our customers. Kelly’s leading placement opportunities for Veterans are within Information Technology, Engineering, Science, Light Industrial and Call Center.
Our specially trained Veteran recruiters are armed with a number of tools to help Veterans obtain roles that match their potential including skill translation tools, leading Veteran- centric job boards and Veteran/spouse social media networks, among others.
Through Kelly’s vast branch network, we are closely located to the majority of major military installations across the United States. Kelly recruiters participate in onsite and virtual military career fairs as well as advertise through local and national Veteran job boards. In recent years, over 150 Kelly branches have worked directly with their local military installations to recruit spouses and transitioning personnel. These teams not only engages with transitioning talent from local bases, but also have a strong focus on Veterans in areas where the military has identified high Veteran unemployment. This approach ensures that military talent is engaged and shared across the centralized military recruiting team and documented in a centralized database, so that other Kelly locations can benefit from hiring or relocating this valuable pool of talent.
Our focus on military recruiting is a win on multiple levels. Kelly gains top talent with the skills needed to excel; our clients receive the benefit of that talent to help them compete in an ever challenging business landscape; and Veterans receive gainful employment in line with their skills and abilities to ease the transition to the next phase of their lives.
A People Company, Staffing the World
Kelly founded the temporary staffing industry in 1946, and has maintained a leadership position through the years based on a valuable premise: we invest in people. Today that focus benefits our customers wherever they operate around the globe - in a growing number of specialized fields. And we’ll continue to meet the evolving challenges of workforce flexibility with staffing solutions tailored to your precise business needs, both locally and worldwide.