QC/Production Associate I

SOFIE; Cleveland (OH); On-site; USD 34,440 - 37,195; Full time

Job summary

SOFIE in Cleveland, OH is seeking a QC/Production Associate I to operate radiosynthesizers for FDG/NaF production and run analytical QC equipment. The role supports cGMP through accurate documentation and adherence to safety procedures.

Candidates should have a high school diploma with preferred associate degree, be detail-oriented, and capable of lifting up to 50 lbs and working varying shifts, including weekends.

Qualifications

• High school diploma required; associate degree in chemistry, engineering, or natural sciences preferred.
• Technical experience with computer-controlled automation preferred.
• Ability to lift ~50 lbs and work varying shifts including weekends.
• Detail-oriented, accountable, patient, organized, and able to work in a team environment required.

Responsibilities

• Operate radiosynthesizers for FDG and NaF production per SOPs.
• Ensure materials/reagents are accepted and within expiry.
• Ensure equipment is qualified and calibrated prior to use.
• Operate synthesis unit and perform routine maintenance.
• Perform QC on equipment and processes per SOPs.
• Maintain cGMP documentation and data records.
• Assist with inventory management and reporting.
• Follow radiation safety and ISO area entry requirements.
• Communicate with local and Network support to troubleshoot issues.

Skills

Detail-oriented

Team collaboration

Communication

Safety conscious

Education

Associate degree in chemistry or related field

Tools

MS Office

Job description

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/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.