QC/Production Associate I

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

Job summary

RPMGlobal in Cleveland, OH is seeking a QC/Production Associate I to operate radiosynthesizers for drug product production and use analytical equipment for quality control. You will perform FDG and NaF synthesis and QC procedures, verify materials per SOPs, and help maintain cGMP records.

Responsibilities include equipment qualification, routine maintenance, inventory management, and supporting QA investigations. Ability to work varied shifts and travel up to 5% is required.

Qualifications

• High school diploma required; associate’s degree in chemistry, engineering, or natural sciences preferred.
• Efficient in MS Office Suite.
• Ability to work various shifts and weekends.
• Detail-oriented, accountable, patient, organized, and team-oriented.
• Able to lift ~50 lbs. and travel up to 5%.

Responsibilities

• Operate radiosynthesizers for FDG and NaF production per SOPs.
• Operate QC equipment and perform quality control processes per SOPs.
• Ensure materials/reagents are within expiry and properly accepted.
• Maintain qualification and calibration of equipment; assist in basic maintenance.
• Complete cGMP documentation and assist QA investigations, CAPAs, deviations.
• Support inventory management and reporting of materials and supplies.
• Communicate with support resources to troubleshoot issues; participate in environmental monitoring.
• Maintain clean, safe work areas and comply with ISO-classified area requirements.

Skills

MS Office Suite

Detail-oriented

Team environment

Professional communication

Shift flexibility

Safety-conscious

Education

Associate's degree in chemistry or natural sciences

Tools

MS Office

Job description

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.