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Reagent Manufacturing Associate

San Jose, CA 95131

Posted: 02/21/2024 Pay Rate: $110k - $120k per year Depending On Experience

Job Description

  • Responsible for product manufacturing of which will include formulations, aseptic aliquoting, product labeling and operating production equipment while following established processes and procedures.
  • Responsible for manufacture of new technology as part of product launch process.
  • Responsible for following production procedures to optimize manufacturing processes and regulatory requirements. Suggests and works with cross-functional teams to implement improvements.
  • Performs in-process testing to assure products meet specifications.
  • Responsible for design packaging for the new products.
  • Writes Manufacturing Batch Records, Bill of Materials for products.
  • Maintains inventory accuracy and integrity through efficient management of product job orders and cycle count activities.
  • Maintains manufacturing documentation in accordance with quality management system.
  • Maintain lab environment to comply with regulatory requirements, and standard operating procedures and good laboratory practices.
  • Maintains laboratory equipment and helps coordinate calibration and service needs.  Manages unique controls, ensuring validation requirements are met.
  • Comply with and support EH&S and quality management system policies and procedures.
  • Handles and uses hazardous materials in production or lab experiments and has knowledge of all safety requirements.
  • Maintains inventory accuracy and integrity through efficient management of job orders and cycle counts.
  • May be responsible for communicating with suppliers for material orders and OEM product schedules.
  • Researches and implements new methods and technologies to enhance production operations.
  • May perform QC laboratory functions such as set-up, operating and maintaining laboratory equipment following standard procedures and methods.
  • Performs functional test inspections to support quality control group as assigned.
  • May be involved in distribution processes such as receiving purchased parts and shipping products or components.
  • Takes the lead for a group assigned task, demonstrating proper techniques and appropriate process control.
  • Works with Production Manager and R&D to transfer products to Production for new product launch.
  • Assists in training and mentoring entry level Production Associates.
  • This position does not have supervisory responsibilities.


How will you get here?
  • BS/MS degree in a scientific discipline such as molecular biology, biochemistry or chemistry is required.
  • Minimum of 8-10 years’ experience in a manufacturing environment with a BS degree. 5-8 years with an MS degree or a combination of education and experience is required.
  • Extensive knowledge and understanding in one of the scientific disciplines noted and a solid background in quantitative methods is required.
  • Strong documentation skills and attention to detail is necessary.
  • Strong communication skills and ability to coordinate work with other team members.
  • Experience in team leadership or mentoring entry level employees.
  • Ability to develop and thoroughly document new processes related to Production and QC procedures.
  • Ability to set up, observe and assess results of experiments, troubleshoot and problem solve to carry out corrective actions.
 

Physical Demands/Work Environment:
  • Maintain a safe, clean and productive work environment.
  • Ability to comply with applicable personal protection equipment.
  • Ability to perform repetitive motion tasks using upper body and while sitting or standing in one place for periods of 1-3 hours of time.
  • While performing the duties of this job, the employee may be required to lift, push, or pull up to 40 lbs. and up to 170 lbs. with assistance or use of tools.
 


 
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About San Jose, CA

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