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QC/Production Associate I
QC/Production Associate ISOFIE • Gilroy, CA, United States
QC / Production Associate I

QC / Production Associate I

SOFIE • Gilroy, CA, United States
30+ days ago
Job type
  • Full-time
Job description

Looking to start or grow your career in science or manufacturing? Join a team where your work truly matters.

At SOFIE, we help create life-saving diagnostic drugs used in medical imaging - and were looking for a detail-oriented, reliable team member to help us make it happen. As a QC / Production Associate I, youll work with high-tech equipment in a clean, controlled lab setting to support the production and testing of important radiopharmaceuticals. Whether you have some lab experience or are looking to get started in a hands-on science or manufacturing role, well train you on everything you need to know.

QC / Production Associate I

Title | QC / Production Associate I

Department | Network Operations

Reports To | Facility Manager

Shift | Production runs from 8PM to 1PM - 8 hour shifts will be between those hours.

Overview

The QC / Production Associate I will operate the radiosynthesizers for the production of drug product, as well as operate analytical equipment for the quality control of drug product.

Essential Duties and Responsibilities

  • Perform FDG and NaF synthesis according to SOFIE Standard Operating Procedures (SOPs) :
  • Ensure all materials / reagents are accepted according to SOPs and within expiry
  • Ensure all equipment is appropriately qualified prior to use
  • Operate the synthesis unit according to SOPs
  • Learn the basic operational principles of the synthesis unit and assist in routine maintenance of the synthesis unit
  • Perform FDG and NaF quality control (QC) processes according to SOPs :
  • Assist with basic maintenance of QC equipment
  • Ensure all equipment is appropriately calibrated and qualified prior to use
  • Operate the QC equipment according to SOPs
  • Ensure completion of applicable cGMP documentation.
  • Assist with inventory management :
  • Maintain production / QC / cleaning supply levels as appropriate
  • Assist with inventory reporting
  • Perform material acceptance according to SOPs
  • Communicate with local and Network support resources to troubleshoot equipment, production, or QC issues.
  • Perform basic computer-controlled cyclotron operations for FDG and NaF production under the advisement of site Cyclotron and Facility Engineer.
  • Maintain a clean and safe working environment.
  • Perform radiation safety duties according to SOFIEs Corporate Radiation Compliance Program and site licensing requirements.
  • Maintain all qualification and validation requirements for entering ISO classified area.
  • Clean classified and non-classified areas according to SOPs.
  • Perform environmental monitoring of classified areas according to SOPs.
  • Report manufacturing metrics into data repository as required.
  • Complete cGMP documents as required and assist site and corporate Quality Assurance including, but not limited to :
  • Investigations
  • Corrective and Preventative Actions
  • Deviations
  • Out of Specifications
  • No or Atypical Yields
  • Manufacturing and QC Records
  • Logbooks
  • Attend internal meetings as required.
  • Other assigned duties as required.

Qualifications

  • High school diploma required; associates degree in chemistry, engineering, or natural sciences preferred.
  • Technical experience with computer-controlled automation preferred.
  • Efficient in the use of MS Office Suite required.
  • Ability to work various shifts and weekends required.
  • Ability to be detail-oriented, accountable, patient, organized, and work in a team environment required.
  • Ability to communicate professionally with colleagues and customers, have excellent attention to detail, and be dependable and responsible in a fast-paced, highly technical environment required.
  • Ability to lift ~50 lbs. required.
  • Up to 5% travel required.

    • PDN-a02343ba-f616-42ba-8f0d-5cd8e51c939d

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