Demo

Quality Assurance Technician - GMP

Cryoport Systems
Irvine, CA Full Time
POSTED ON 3/1/2025
AVAILABLE BEFORE 4/25/2025

POSITION SUMMARY

The Quality Assurance Technician is responsible for performing preliminary inspection on prototype, pre-release products and final Quality Assurance process Control Checks on selected outgoing shipments while also monitoring and maintaining the Quality System processes and documentation. This role also assists Quality Engineering in various in-house studies and/or validation activities, coordinating calibration activities and reviewing/uploading calibration certificates into Cryoportal.

Primary Responsibilities include but are not limited to:

  • Performs an incoming inspection, both mechanical and functional, for all newly purchased commodities per part-specific Quality Inspection Plan. This includes, but is not limited to, the following critical items: cellular command modules, advanced battery packs, dewars, etc.
  • Assists in performing preliminary troubleshooting for the questionable equipment which was linked to either customer complaint or internal rejection per established testing protocols.
  • Identifies non-conforming material and initiates NCR’s (Non-Conforming Material Reports)
  • Reviews the overall correctness of calibrated equipment utilized for shipment (TCs, thermistors, data loggers) versus the calibration certificates prior to uploading the certificates into the portal.
  • Reading Process Control and instruction to fully comprehend the requirement for the active shipments and performing a quality check accordingly.
  • Training new Quality Assurance associate team members
  • Assisting Quality Engineering in testing and/or validating process
  • Assisting Quality Engineering in revising testing protocol (TP) and/or Work Instruction (WI) to reflect current practice

Competencies and Personal Attributes:

  • Ability to be involved in teams and meetings as assigned
  • Possesses exceptional verbal and written communication skills
  • Strong self-motivation and the ability to work independently
  • Organization and prioritization skills with excellent attention to detail
  • Able to understand and comply with established company policies and procedures
  • Passion and alignment with our mission, vision, values & operating principles
  • Passion for working in a values-based company in alignment with a learning organization
  • Desire to make own decisions and take responsibility for outcomes
  • A willingness to continually embrace personal and professional development.

Qualification and Educational Requirements:

  • High School Diploma or equivalent
  • At least two (2) years’ inspection experience
  • Able to read and interpret part drawing and/or quality specifications
  • Able to apply good inspection techniques with minimal supervision
  • Strong analytical and problem-solving skills
  • Able to use various types of hand-held inspection equipment (calipers, micrometers, force gage, height gage, etc.).
  • Able to enter information into data collection software (i.e. Excel Spreadsheet)
  • Computer literacy
  • Detail oriented with exceptional organizational skills

Preferred Skills:

  • Prior knowledge of GMP and GDP
  • Familiar with First Article Inspection.
  • Familiar with GD&T concept.

Compensation: up to $29 hr, commensurate with experience

Cryoport Systems is an Equal Opportunity Employer offering competitive compensation with a generous benefits package that includes health insurance, a 401K with company match and stock equity (Nasdaq: CYRX).

To learn more about Cryoport Systems, please visit https://www.cryoport.com/

Job Types: Full-time, Permanent

Pay: Up to $29.00 per hour

Benefits:

  • 401(k)
  • 401(k) matching
  • Dental insurance
  • Flexible spending account
  • Health insurance
  • Health savings account
  • Life insurance
  • Paid time off
  • Vision insurance

Schedule:

  • 8 hour shift
  • Monday to Friday

Work Location: In person

Salary : $29

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