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Quality Control Production Technician

2 months ago

Gilroy, United States Kelly Science, Engineering, Technology & Telecom Full time

Quality Control Production Technician - Gilroy, CA

Summary:

The QC/Production Associate I is responsible for operating radiosynthesizers for drug product production and analytical equipment for quality control. This role involves following standard operating procedures (SOPs) to ensure the safe and effective production and quality control of FDG and NaF, maintaining inventory, and adhering to cGMP documentation and safety regulations.

Details:

  • Pay rate: $31 - $32/hr
  • Shift:
  • Morning shift; start time between 12am - 2am with 8hr shifts
  • Additionally, Saturday work roughly every 4 weeks
  • Duration: Direct-hire (permanent position)
  • Relocation assistance available

Responsibilities:

  • Perform FDG and NaF synthesis according to SOPs.
  • Ensure materials/reagents are accepted according to SOPs and within expiry.
  • Operate and maintain synthesis units.
  • Conduct FDG and NaF quality control processes.
  • Calibrate and qualify QC equipment.
  • Complete applicable cGMP documentation.
  • Assist with inventory management and reporting.
  • Communicate with support resources for troubleshooting.
  • Perform basic computer-controlled cyclotron operations.
  • Maintain a clean and safe working environment.
  • Follow radiation safety duties according to corporate compliance and licensing.
  • Maintain qualification and validation for ISO classified areas.
  • Clean and monitor classified and non-classified areas.
  • Report manufacturing metrics into data repositories.
  • Assist with site and corporate Quality Assurance activities, including investigations, corrective actions, deviations, and record-keeping.
  • Attend internal meetings and perform other assigned duties as required.

Qualifications:

  • High school diploma required; associate's or bachelor's degree in chemistry, engineering, or natural sciences a plus.
  • Experience within a GMP environment a plus
  • Ability to work various shifts and weekends required.
  • Detail-oriented, accountable, patient, organized, and able to work in a team environment.
  • Professional communication skills, excellent attention to detail, and dependability in a fast-paced, highly technical environment.
  • Ability to lift approximately 50 lbs.


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