Senior Quality Assurance Specialist

Kelly® Science & Clinical is seeking a Senior Quality Specialist for a two-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 and diagnostics industries.

Workplace : Onsite in Sunnyvale, CA

Position Title : Senior Quality Specialist

Position Type : Two-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 the 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.