QC/Production Associate I
Title | QC/Production Associate I
Department | Network Operations
Reports To | Facility Manager
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 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:
- Corrective and Preventative Actions
- Deviations
- Out of Specifications
- No or Atypical Yields
- Manufacturing and QC Records
- 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.
