QC/Production Associate III

SOFIE; Totowa (NJ); On-site; USD 80,000 - 85,000; Full time

Job summary

SOFIE in Totowa, NJ is seeking a QC/Production Associate III to operate radiosynthesizers and analytical equipment for drug product quality control. The role includes training responsibilities and ensuring cGMP documentation compliance.

Responsibilities cover synthesis, QC processes, calibration/qualification, inventory, safety, and cross-functional support within the Network Operations department. The position requires experience in radiopharmaceutical environments and the ability to work

Qualifications

• Requires 6+ years of radiopharmaceutical manufacturing and QC experience.
• Experience with FDG and NaF production and QC is preferred.
• Familiarity with cGMP documentation and ISO environment is expected.

Responsibilities

• Operate and maintain radiosynthesizers for drug product.
• Maintain QC equipment and ensure calibration/qualification before use.
• Perform training duties for QC/Production personnel as applicable.
• Complete cGMP documentation and investigations as required.
• Inventory management and material acceptance per SOPs.
• Assist with environmental monitoring and safety compliance.

Skills

Automation software

MS Office

Attention to detail

Team collaboration

Education

High school diploma

Associates degree in chemistry/engineering/natural sciences

Tools

Semi-preparative HPLC

Cyclotron control systems

Job description

Overview

The QC/Production Associate III will operate and maintain the radiosynthesizers for the production of drug product, as well as operate and maintain analytical equipment for the quality control of drug product. They will also aid the Facility Manager in training of QC/Production personnel as applicable.

• Perform FDG, NaF, and 1-2 other products’ 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 semi-preparative HPLC and perform routine maintenance of the synthesis unit and semi-preparative HPLC
• Perform FDG, NaF, and 1-2 other products’ quality control (QC) processes according to SOPs:
• Perform basic maintenance and qualification of QC equipment
• Ensure all equipment is appropriately calibrated and qualified prior to use
• Operate the QC equipment according to SOPs
• Prepare reagents for QC
• Perform troubleshooting of QC equipment under advisement of Corporate QC Department or others
• Ensure completion of applicable cGMP documentation.
• Perform inventory management:
• Maintain production/QC/cleaning supply levels as appropriate
• Perform 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, NaF, and 1-2 other products’ 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
• Assist with training of QC/Production Associate I personnel.
• Attend internal meetings as required.
• Other assigned duties as required.

Description

Title | QC/Production Associate III

Location | Totowa,NJ

Department | Network Operations

Reports To | Facility Manager

Compensation- $80,000 - $85,000/yr

The QC/Production Associate III will operate and maintain the radiosynthesizers for the production of drug product, as well as operate and maintain analytical equipment for the quality control of drug product. They will also aid the Facility Manager in training of QC/Production personnel as applicable.

Essential Duties And Responsibilities

• Perform FDG, NaF, and 1-2 other products’ 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
• Operate a semi-preparative HPLC system
• Learn the basic operational principles of the synthesis unit and semi-preparative HPLC and perform routine maintenance of the synthesis unit and semi-preparative HPLC
• Perform FDG, NaF, and 1-2 other products’ quality control (QC) processes according to SOPs:
• Perform basic maintenance and qualification of QC equipment
• Ensure all equipment is appropriately calibrated and qualified prior to use
• Operate the QC equipment according to SOPs
• Prepare reagents for QC
• Perform troubleshooting of QC equipment under advisement of Corporate QC Department or others
• Ensure completion of applicable cGMP documentation.
• Perform inventory management:
• Maintain production/QC/cleaning supply levels as appropriate
• Perform 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, NaF, and 1-2 other products’ 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
• Assist with training of QC/Production Associate I personnel.
• Attend internal meetings as required.
• Other assigned duties as required.

Qualifications

• High school diploma required; associates degree in chemistry, engineering, or natural sciences preferred.
• 6-years’ experience in radiopharmaceutical manufacturing and quality control required.
• Technical experience with computer-controlled automation required.
• 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 10% travel required.