QC/Production Associate I Position Available In DeKalb, Georgia

Job Description:

QC/Production Associate I Skills, Experience, Qualifications, If you have the right match forthis opportunity, then make sure to apply today. Title

• QC/Production Associate I Department
• Network Operations Reports To
• Facility Manager Overview The QC/Production Associate I will operate the radiosynthesizersfor the production of drug product, as well as operate analyticalequipment for the quality control of drug product.

Essential Duties and Responsibilities Perform FDG and NaF synthesis according to SOFIE Standard OperatingProcedures (SOPs): Ensure all materials/reagents are accepted according to SOPs andwithin 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 andassist 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 qualifiedprior 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 totroubleshoot equipment, production, or QC issues. Perform basic computer-controlled cyclotron operations for FDG andNaF production under the advisement of site Cyclotron and FacilityEngineer. Maintain a clean and safe working environment. Perform radiation safety duties according to SOFIE’s CorporateRadiation Compliance Program and site licensing requirements. Maintain all qualification and validation requirements for enteringISO classified area. Clean classified and non-classified areas according to SOPs. Perform environmental monitoring of classified areas according toSOPs. Report manufacturing metrics into data repository as required. Complete cGMP documents as required and assist site and corporateQuality 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 automationpreferred. 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, andwork in a team environment required. Ability to communicate professionally with colleagues andcustomers, have excellent attention to detail, and be dependableand responsible in a fast-paced, highly technical environmentrequired. Ability to lift

• 50 lbs.

required. Up to 5% travel required.