Glenwillow, Ohio

QC/Production Associate

Direct hire/salaried

 

Overview: The QC/Production Associate will operate and maintain the radiosynthesizers for the production of drug product, as well as operate and maintain analytical equipment for the quality control of drug product. They will also aid the Facility Manager in training of QC/Production personnel as applicable.

 

Shift Options: The position requires training and periodic work on the 11pm-7am shift.  After training, the incumbent will have flexibility to work a later schedule (4am-12pm, 5am-1pm or 6am-2pm), but periodically will be required to shift back to the overnight shift. Some additional support on Saturdays may be required as production demands.

 

Essential Duties and Responsibilities:

  • Perform FDG, NaF, and 1-2 other products’ 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
  • Operate a semi-preparative HPLC system
  • Learn the basic operational principles of the synthesis unit and semi-preparative HPLC and perform routine maintenance of the synthesis unit and semi-preparative HPLC
  • Perform FDG, NaF, and 1-2 other products’ quality control (QC) processes according to SOPs:
    • Perform basic maintenance and qualification of QC equipment
    • Ensure all equipment is appropriately calibrated and qualified prior to use
    • Operate the QC equipment according to SOPs
    • Prepare reagents for QC
    • Perform troubleshooting of QC equipment under advisement of Corporate QC Department or others
  • Ensure completion of applicable cGMP documentation.
  • Perform inventory management:
    • Maintain production/QC/cleaning supply levels as appropriate
    • Perform 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, NaF, and 1-2 other products’ production under the advisement of site Cyclotron and Facility Engineer.
  • Maintain a clean and safe working environment.
  • Perform radiation safety duties according to 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
  • Assist with training of QC/Production Associate I personnel.
  • Attend internal meetings as required.
  • Other assigned duties as required.

     

Qualifications

  • High school diploma required; Bachelor’s degree in chemistry, engineering, or natural sciences preferred.
  • 2-years’ experience in manufacturing and quality control required.
  • Experience in radiopharmaceutical industry is preferred.
  • Technical experience with computer-controlled automation required.
  • 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 10% travel required.


Why Kelly®?

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

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Glenwillow, Ohio

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