QC/Production Associate I at SOFIE
Oakwood Village, OH 44146
About the Job
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:
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.
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:
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.