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Quality Compliance Specialist (Fremont, CA)

Quality Compliance Specialist

Fremont, CA

Temp To Hire

 

Our client provides solutions for biomolecular analysis, including real-time analysis of biomolecular interactions in micro-volume samples size, providing information on binding affinity, binding kinetics and concentration. Their products include instrumentation, software, biosensors and supporting services.

The Quality Compliance Specialist will be responsible for administering quality systems using basic skills and knowledge of appropriate procedures, methods and techniques, as well as applicable current good manufacturing practice and customer requirements. The holder of this position will help to ensure implementation, maintenance, and improvement of the quality system.

 

Main Responsibilities Tasks:

  • Write and review Standard Operating Procedures SOPs
  • Support ongoing process improvement endeavors
  • Maintain and ensure applicable regulatory and internal QMS compliance for staff training/personnel files, master schedule, deviation trending/tracking, etc.
  • Provide support for internal and sponsored projects including reviewing protocols and reports
  • Work collaboratively with staff responding to and resolving deviations and incidents
  • Follow through on corrective and preventative actions from deviations and audit observations
  • Maintain databases for investigations, audit observations and CAPA Qualifications

Skills:

  • Bachelor s degree in Science, Engineering or related field
  • 3-5 years related experience required
  • Knowledge of requirements and relevant industry standard practices with a demonstrated ability to interpret these regulations to ensure proper implementation in the quality systems
  • Knowledge of quality systems and product/process lifecycle management within a manufacturing environment
  • Proficient computer skills required
  • Excellent communications skills both written and oral, including ability to navigate potentially challenging situations both internal and external to the business during the coordination of QMS programs
  • Ability to quickly assess assigned task requirements, identify potential challenges, and communicate effectively in order to expedite the successful execution of assigned work
  • Efficient organizational skills, including the ability to manage multiple processes and priorities effectively
  • Ability to read, write and speak fluent English

Why Kelly®?

Kelly® Science 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 interests—it’s 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, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re 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.

Kelly complies with the requirements of the Fair Chance Initiative. A conviction record does not automatically bar individuals from employment.

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