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Quality Control Associate

Santa Clara, CA 95050

Posted: 06/07/2024 Employment Type: Contract Job Category: Quality and Compliance Job Number: 607984 Is job remote?: No Country: United States

Job Description


Target Pay Rate: 25-31/hr **salary will be commensurate with experience 
 

Job Description:

The Quality Control Associate – Sequencing Cartridge Operations will be an integral part of a team that performs cartridge assembly and systems testing. This individual will be responsible for the setup, execution, monitoring and data analysis of all Quality Control release activities associated with the Sequencing Process.

The individual will be responsible for review, generation and sign-off of quality documentation. The ideal candidate will be responsible for interfacing with highly complex systems and controls in an ISO 13485 and cGMP manufacturing environment. The individual will maintain areas in high state of inspection preparedness by maintaining equipment, records and laboratory environment in order to comply with regulatory requirements utilizing current regulations and Operating Procedures (OP). Additionally, maintains production documents and investigates laboratory exception events and works independently with general guidance from senior team members

Requirements:

Education: HS Diploma Min. and 4 years of exp.
Associate's Degree: 3 years of exp.
BS Degree: 1+ years of exp

Knowledge, Skills and Abilities:
 
  • Excellent oral and written communication skills demonstrated by communicating with other functions and management regarding resolving testing, investigations and theory
  • Strong data-analysis skills, with clear demonstrated understanding of analytical, troubleshooting and problem solving skills.
  • Proven math skills
  • Hands on experience in a laboratory 
  • Accurate and precise manual pipetting and measuring techniques 
  • Demonstrated attention to detail and strong organizational skills 
  • Ability to utilize electronic office suite of computer programs 
  • Proven ability to meet deadlines and work under aggressive timelines 
  • Demonstrated ability to work effectively in a team environment 
  • Experience working in GLP, cGMP or ISO regulated environment 
  • Experience with 6S and Lean techniques 
  • Experience with handling corrosive and biohazardous reagents
  • Work is performed in a laboratory environment 
  • Schedule could include overtime and shift work in the future as business needs require 
  • Lifting up to 25lbs may be required 
  • Environment may require gowning, hair net, safety glasses, gloves and foot coverings.
  • May work with hazardous materials and chemicals


Responsibilities:

? Performs setup, execution and monitoring of Sequencing process for the Quality Control release of cartridge assemblies.
? Prepares sequencing platform equipment, test equipment and materials as required per procedure
? Conduct data analysis of test results and determine Quality acceptability per approved procedures
? Responsible for generating compliant QC documentation as part of the Device History Record, observations, test results and reports required for releasing items into inventory from the raw material to the in-process finished goods and final products.
? Perform a variety of QC duties relating to production manufacturing, including incoming and in-process QC inspections
? Maintain records and QC lab environment to comply with cGMP, OP and regulatory requirements
? Support 6S effort and continuous improvement to streamline overall operations and improve efficiency? Assist in performing maintenance of laboratory equipment
? Assist in regular laboratory and manufacturing environmental monitoring testing
? Assist in reagent and lab supply ordering and inventory management in order to support the QC laboratory
? Ensures equipment is in compliance with calibration standards
? Foster and follow an established safety culture, environmental guidelines and procedures for all work performed
? May assist with troubleshooting and investigation of QC failures by working with others
? May assist in transferring processes from development to QC
? May assist in testing raw materials for reliability and stability
? May assist in process monitoring and trending
? May assist in collecting, interpreting and communicating process metrics for recommended improvements
? May assist in performing, reviewing and/or generating validations for QC processes and laboratory equipment
? Other duties as assigned.
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About Santa Clara, CA

Ready to take the next step in your career? Explore our job opportunities in the vibrant area around Santa Clara, California. Located in the heart of Silicon Valley, this region offers unparalleled growth opportunities in tech, innovation, and beyond. With attractions like Levi's Stadium, the Santa Clara Convention Center, and the nearby California's Great America theme park, there's always something exciting to do. Indulge in the diverse culinary scene, catch a show at the Triton Museum of Art or the historic Santa Clara Theatre, or cheer for the San Francisco 49ers at Levi's Stadium. Discover why Santa Clara is the perfect place to elevate your career and enjoy a rich blend of culture and charm!

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