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QC/Production Associate I

$25 - $27 per hour

SOFIE

QC/Production Associate I

QC/Production Associate I

Network Operations

Facility Manager

$25-$27

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 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 SOFIE's 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
Vacancy posted 3 days ago
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