QC/Production Associate III

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

Job summary

RPMGlobal in Totowa, NJ is seeking a QC/Production Associate III to operate radiosynthesizers and analytical equipment for drug product production and QC. You will ensure materials and equipment meet SOPs, maintain cGMP documentation, and support cross-functional training within a fast-paced, highly technical environment.

The role requires experience in radiopharmaceutical manufacturing, strong automation skills, and the ability to lift up to 50 lbs while working shifts.

Qualifications

• High school diploma required; associate degree preferred in chemistry/engineering/natural sciences.
• 6+ years’ experience in radiopharmaceutical manufacturing and quality control.
• Technical experience with computer-controlled automation required.
• Efficient in MS Office Suite.
• Ability to work various shifts and weekends.
• Detail-oriented, accountable, patient, organized, and a team player.
• Ability to communicate professionally with colleagues and customers.
• Ability to lift up to 50 lbs.
• Up to 10% travel required.

Responsibilities

• Operate and maintain radiosynthesizers for production of drug product per SOPs.
• Operate and maintain analytical equipment for QC of drug product.
• Assist Facility Manager in training QC/Production personnel.
• Ensure materials, reagents, and equipment meet SOPs and expiry/qualification requirements.
• Maintain cGMP documentation and perform inventory management.
• Troubleshoot equipment with corporate QC and support resources.
• Perform environmental monitoring and ISO classification activities.
• Assist with training of QC/Production staff and participate in internal meetings.

Skills

Radiopharmaceutical production

Quality control

Computer-controlled automation

MS Office

Teamwork

Detail-oriented

Shift work

Communication

Physical stamina

Education

High school diploma

Associate degree in chemistry/engineering/ sciences

Tools

Semi-preparative HPLC

SOP adherence

Job description

QC/Production Associate III

Title |QC/Production Associate III

Location | Totowa,NJ

Department |Network Operations

Reports To |Facility Manager

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

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.

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 principlesof the synthesis unit and semi-preparative HPLC and perform routine maintenance of the synthesis unitand 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/cleaningsupply levels as appropriate
• Perform inventory reporting
• Perform material acceptanceaccordingto 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’ experiencein 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.