Quality Control Production Associate

Quality Control Production Associate

Full-Time | Pharmaceutical Manufacturing & Quality Control

Position Overview

The Quality Control Production Associate is an entry-level scientific position that plays a key role in producing life-changing PET drug products and research materials while ensuring their quality through hands-on work with advanced laboratory equipment and analytical instruments.

This position is ideal for recent graduates and early-career professionals seeking hands-on experience in pharmaceutical manufacturing, quality control, laboratory operations, and radiopharmaceutical production. Successful candidates will receive comprehensive on-the-job training in PET radiopharmaceutical manufacturing, radiation safety, cGMP practices, quality control testing, and cyclotron operations.

Schedule

Full-Time, Monday through Friday

This position participates in a rotating production schedule:

• 4 weeks on Day Shift
• 2 weeks on Night Shift
• Occasional on-call responsibilities
• Occasional weekend coverage as part of a shared team rotation

Candidates should be comfortable working both day and night shifts as business needs require.

About 3D Imaging

3D Imaging is a small contract research company specializing in the production and use of radiopharmaceuticals, primarily for PET imaging. We also operate a medical cyclotron facility producing radiopharmaceuticals for clinical trials and research use.

Our clients include pharmaceutical and biotechnology companies, governmental agencies such as the NIH, NCTR, and FDA, and investigators at UAMS. Our work incorporates synthetic organic chemistry, inorganic chemistry, radiochemistry, pharmaceutical manufacturing, and quality assurance.

Reports To: FDG Manager, Laboratory Director

Key Responsibilities

This position is designated as a Safety-Sensitive Position. The essential functions, physical demands, and mental competencies of this role require employees to maintain the ability to work in a constant state of alertness and perform work safely at all times.

• Perform FDG synthesis according to 3D Imaging Standard Operating Procedures (SOPs).
• Ensure all materials and reagents are received, inspected, and documented in accordance with SOPs and cGMP requirements.
• Operate automated FDG synthesis systems, including equipment setup, reagent loading, process monitoring, and production documentation.
• Operate, monitor, and document cyclotron and synthesis activities under supervision.
• Conduct in-process checks and assist with quality control testing, including dose calibrator measurements, pH testing, and visual inspections.
• Complete batch records and manufacturing documentation accurately and in a timely manner.
• Support equipment cleaning, environmental monitoring, preventive maintenance, and laboratory housekeeping activities.
• Maintain hot cells, laminar flow hoods, production equipment, tools, and supporting laboratory systems.
• Adhere to all radiation safety, aseptic processing, quality assurance, and regulatory compliance requirements.
• Package, label, and prepare finished doses for shipment and distribution.
• Report deviations, equipment concerns, safety incidents, or out-of-specification results promptly to management.
• Perform additional duties and responsibilities as assigned.

Qualifications and Requirements

• Bachelor's degree in Chemistry, Biochemistry, Biology, Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences, Physics, Radiologic Sciences, or a related scientific field required.
• Familiarity with laboratory analytical techniques gained through academic coursework, research, internships, or industry experience.
• Strong organizational skills and attention to detail with data, documentation, and recordkeeping.
• Excellent problem-solving and written/verbal communication skills.
• Willingness to work with radioactive materials and follow strict safety procedures.
• Proficiency in Microsoft Excel, Microsoft Word, and other standard computer applications.
• Ability to work independently and collaboratively in a dynamic team environment.
• Ability to lift up to 50 pounds.
• Willingness to work a rotating shift schedule.
• Excellent judgment and discretion with the ability to manage multiple priorities, meet deadlines, and work effectively under pressure.
• Self-motivated professional with the ability to learn complex laboratory processes, production systems, and technical equipment through structured training and progressive responsibility.
• Willingness to learn and adapt in a fast-paced, highly technical environment.

Preferred Qualifications

• Degree concentration in Chemistry, Biochemistry, Radiochemistry, Chemical Engineering, Pharmaceutical Sciences, or a related discipline.
• Experience in laboratory, pharmaceutical manufacturing, quality control, research, or regulated production environments.
• Experience with coding or scripting languages such as Python, MATLAB, R, or similar platforms for data analysis or process optimization.
• Basic mechanical aptitude, including familiarity with common hand and power tools.
• Introductory knowledge of electrical components, wiring, and safe work practices.
• Experience operating, calibrating, maintaining, or troubleshooting laboratory instrumentation such as HPLC, GC, TLC, or related analytical systems.
• Familiarity with cGMP, FDA, USP, or other regulated manufacturing and quality systems.
• Experience handling radioactive materials (RAM).
• Experience preparing radiolabeled compounds or radiopharmaceuticals.
• Ability to read, interpret, and communicate technical information from manuals, procedures, and equipment documentation.
• Basic familiarity with cyclotron operation, maintenance, and support systems.

On-the-Job Training

This role is ideal for a recent graduate or early-career professional seeking hands-on experience in pharmaceutical manufacturing, laboratory operations, quality control, and radiopharmaceutical production.

As a Quality Control Production Associate, you will receive training in:

• Safe handling of radioactive materials and associated equipment
• Radiation safety and contamination control practices
• PET radiopharmaceutical manufacturing and FDG production
• Basic cyclotron operation and support systems
• Cyclotron target installation and radionuclide processing
• cGMP pharmaceutical manufacturing requirements
• Quality control testing and analytical techniques
• Equipment maintenance, repair, and calibration
• Manufacturing documentation and regulatory compliance

Physical Demands

This position requires regular movement throughout the workday and frequent interaction with laboratory and production equipment.

Employees must be able to:

• Lift and move up to 50 pounds on an occasional basis
• Walk, stand, bend, stoop, push, and pull throughout the workday
• Perform repetitive laboratory and manufacturing tasks
• Wear required personal protective equipment and radiation monitoring devices
• Work safely around production and laboratory equipment

Join a team that supports groundbreaking medical research and clinical innovation while developing specialized skills in one of the most unique areas of pharmaceutical manufacturing.