QC/Production Associate I

QC/Production Associate I

Title: QC/Production Associate I | Department: Network Operations | Reports To: Facility Manager | Compensation: $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 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, and 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; associate’s 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.