QC/Production Associate I

RPMGlobal; Totowa (NJ); On-site; USD 35,000 - 55,000; Full time

Job summary

Join a forward-thinking company as a QC/Production Associate I, where you will be integral to drug product production and quality control. This role involves operating radiosynthesizers and analytical equipment, ensuring compliance with SOPs, and maintaining a safe work environment. Ideal candidates will possess strong communication skills, attention to detail, and the ability to work various shifts. You'll contribute to the production of critical pharmaceuticals while adhering to high standards of quality and safety. If you're ready to make a difference in the healthcare industry, this is the opportunity for you.

Qualifications

• High school diploma required; associate degree preferred.
• Experience with computer-controlled automation preferred.
• Ability to lift approximately 50 lbs.

Responsibilities

• Operate radiosynthesizers for drug product production.
• Perform quality control processes according to SOPs.
• Maintain a clean and safe working environment.

Skills

Detail-oriented

Communication Skills

Team Player

Computer-Controlled Automation

MS Office Proficiency

Education

High School Diploma

Associate Degree in Chemistry, Engineering, or Sciences

Tools

Analytical Equipment

Radiosynthesizers

Computer-Controlled Cyclotron Systems

Job description

QC/Production Associate I

Title: QC/Production Associate I

Department: Network Operations

Reports To: Facility Manager

Overview

The QC/Production Associate I operates radiosynthesizers for drug product production and analytical equipment for quality control.

Essential Duties and Responsibilities

1. Perform FDG and NaF synthesis according to SOPs.
2. Ensure all materials/reagents are accepted according to SOPs and are within expiry.
3. Ensure all equipment is qualified prior to use.
4. Operate the synthesis unit according to SOPs.
5. Assist in routine maintenance of the synthesis unit.
6. Perform FDG and NaF quality control processes according to SOPs.
7. Assist with maintenance and calibration of QC equipment.
8. Complete cGMP documentation accurately.
9. Manage inventory levels and reporting.
10. Perform material acceptance as per SOPs.
11. Troubleshoot equipment, production, or QC issues with support resources.
12. Operate computer-controlled cyclotron systems under supervision.
13. Maintain a clean and safe working environment, adhering to radiation safety protocols.
14. Maintain qualification and validation standards for ISO classified areas.
15. Clean and monitor classified and non-classified areas as per SOPs.
16. Report manufacturing metrics and complete cGMP documents.
17. Assist with investigations, CAPAs, deviations, and record keeping.
18. Attend internal meetings and perform other duties as assigned.

Qualifications

• High school diploma required; associate degree in chemistry, engineering, or sciences preferred.
• Experience with computer-controlled automation preferred.
• Proficiency in MS Office required.
• Ability to work various shifts, including weekends.
• Detail-oriented, organized, team player, and dependable.
• Excellent communication skills.
• Ability to lift approximately 50 lbs.
• Up to 5% travel required.