Quality Assurance Specialist

2 weeks ago

Springfield, New Jersey, United States Evergreen Theragnostics Full time
About Evergreen Theragnostics

We are a radiopharmaceutical company headquartered in New Jersey, operating in a state-of-the-art facility. Our team provides contract development and manufacturing services for radiopharmaceutical companies, including therapeutics and diagnostics. We also conduct cutting-edge cancer research, developing proprietary medicines.

We are a small, collaborative team where all members support each other in various activities. We are looking for team members who are motivated to take on new challenges and excited to contribute to our growth.

Job Description

The Quality Control Technician is responsible for performing time-sensitive quality control tests on radioactive drug products and materials. This role involves operating and maintaining analytical instrumentation, performing routine calibrations, and preparing chemical reagents for manufacturing.

Key Responsibilities
  • Perform QC stability testing, maintaining stability records and summaries.
  • Train and transfer methods to and from QC and contract manufacturers as assigned.
  • Support the modification and validation of analytical procedures to meet QC's needs.
  • Contribute to the design and development of experimental protocols, SOPs, and other documents consistent with cGMP/GLP.
  • Conduct quality QC chemical tests for batch release.
  • Participate in special projects and department meetings via input, feedback, and execution of assigned tasks.
  • Execute special projects on analytical and instrument problem solving.
  • Perform timely radioactive and microbiological QC and record product quality.
  • Adapt, maintain, and operate analytical instrumentation.
  • Ensure a clean, safe, and compliant work environment.
  • Conduct radiation safety duties in accordance with regulations.
  • Report monthly on supplies for QC orders involving devices and reagents.
  • Contribute to industrial, R&D qualification, and validation activities and support routine maintenance.
  • Lead laboratory investigations and root-cause analyses.
  • Prepare chemical reagents for manufacturing and QC.
Requirements
  • Bachelor's Degree in a science field (Chemistry, Biology, etc.) required, along with a minimum of 1 year of lab experience.
  • Experience using analytical techniques, such as HPLC and rTLC.
  • Excellent oral and written communication, organizational, and problem-solving skills while working under strict timelines.
  • Ability to convey complex ideas in a simple manner to management and customers, exercise independent judgement during method development/transfer processes.
  • Team-oriented mindset and ability to work easily with cross-functional teams.
  • Fluent in Microsoft Word and ability to acclimate to new software.
  • Strong background in microbiology preferred.

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