QC Production Associate

SOFIE Inc.; New Jersey; On-site; USD 33,000 - 39,000; Full time

Job summary

RPMGlobal in Somerset, NJ is seeking a QC/Production Associate I to operate radiosynthesizers for drug product production and to run QC analytical equipment in a highly regulated setting. You will ensure SOP compliance, participate in safety and compliance programs, and support documentation in a fast-paced environment.

Work involves operating the synthesis and QC equipment, maintaining calibration, and contributing to inventory management and data reporting under supervision.

Qualifications

• High school diploma required; associates degree in chemistry, engineering, or natural sciences preferred.
• Technical experience with computer-controlled automation.
• Efficient in MS Office Suite.

Responsibilities

• Operate radiosynthesizers for FDG and NaF production.
• Perform QC processes on drug products per SOPs.
• Ensure materials and equipment meet SOPs and expiry requirements; calibrate as needed.
• Maintain cGMP documentation and assist with investigations.
• Support inventory management and reporting; ensure proper logbooks.

Skills

Technical experience with computer‑dr

Attention to detail

Education

High school diploma

Associates degree in chemistry or natural sciences

Tools

MS Office Suite

Job description

Title | Quality Control (QC) / Production Associate I (Chemist)

Location | Somerset,NJ

Department | Network Operations

Reports To | Facility Manager

Compensation range | $24 - $28/hr

Overview

The QC/Production Associate I will operate the radiosynthesizers for the production of drug products, as well as operate analytical equipment for the quality control of drug products.

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.
• Responsible for opening change controls and initiating, maintaining, and reviewing SOFIE network and site‑specific procedures relative to their job functions.
• 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 is required.