Quality Specialist I

Location: San Jose, CA
Department: Azzur Labs, LLC

Job Description

Azzur Labs is seeking a Quality Specialist I for their CA Laboratory. The Quality Specialist I supports the company’s quality assurance and control programs. The Quality Specialist I is responsible for document review and control, inventory control, and quality control of incoming materials. The Quality Specialist I will assist the Quality Manager in assuring that the quality management system is implemented and followed.

WORKING DAYS: MONDAY- FRIDAY 

Job responsibility:

  1. Ensures all incoming materials are tested and found to be of acceptable quality before use.
  2. Responsible for assisting in the conduct of internal audits.
  3. Assists in conducting investigations of laboratory deviations and client exceeded concern levels.
  4. Maintains training records and documentation.
  5. Reviews documentation, such as raw data and reports (Environmental monitoring, water, media fill, bioburden), logbooks (beginner to intermediate level), quality control records, and quality assurance records for completeness, accuracy, and compliance with methods, protocols, guidelines, regulations and Azzur Labs LLC quality systems.
  6. Assures proper control of laboratory testing as needed for review.
  7. Maintains familiarity with laboratory testing as needed for review.
  8. May draft or review client notifications of exceeded levels.
  9. Collaborates with the implementation, maintenance, and improvement of quality systems.
  10. Reads standards, journals, and publications to keep abreast with requirements and developments in applicable technologies.

Requirements

  • 1-3 years of experience in a regulated industry, preferably in quality or laboratory operations.
  • Previous experience in batch record or documentation review.

Preferred Experience

  • Experience in a regulated industry, preferably in pharmaceuticals or medical device
  • Hands-on experience working in a microbiology laboratory
  • American Society for Quality Certified Quality Technician or other certification

Required Education
          High School Diploma, 3 - 5 years of experience in a quality roleBachelors degree,
          1 - 3 years of experience in a role

Preferred Education
        Bachelor of Science or Bachelor of Arts in a science or engineering field

Benefits

Fulltime Employment with Azzur can offer you:

  • Flexible PTO
  • Training and Development Opportunities
  • 401(k) match
  • Bonus Eligibility
  • Medical Benefits
  • Paid Holidays
  • Company provided laptop

Who we are:

Who we are:

Azzur Group is dedicated to providing clients with efficient, innovative quality and compliance solutions from Discovery to Delivery™. With more than 500 industry partners, including 80% of the top pharma/biotech manufacturers in the U.S., Azzur Group provides carefully calibrated and efficiently executed project management, process engineering, and compliance services. As one of the fastest-growing private companies in America, Azzur Group provides clients with consulting, facility solutions, engineering, validation, IT, technical, training, COD, laboratory services, and solutions they need to remain innovative and competitive.

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