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Quality Control Technician
3 months ago
About Evergreen
Evergreen Theragnostics, Inc. is a radiopharmaceutical company based in Springfield, NJ. We operate in a brand-new state-of-the-art facility, focusing on CDMO services as well as commercialization of our own portfolio radiopharmaceutical products. W
Job Description
The QC Technician is responsible for performing all time-sensitive quality control tests on radioactive drug products and materials. The QC chemist shall also operate and maintain all analytical instrumentation and perform routine calibrations on laboratory equipment. The QC Technician shall prepare chemical reagents for manufacturing as well as ensuring lab cleanliness and radiation safety standards are always maintained.
Responsibilities
- Perform QC stability testing, by preparing and maintaining stability records and summaries.
- Training and transfer of methods to and from QC and contract manufacturers as assigned.
- Support the modification and validation of analytical procedures to meet QC’s needs.
- Work on the design and development of experimental protocols, SOP’s, etc., consistent with cGMP/GLP.
- Conduct all quality QC chemical tests for release of batches for patient use.
- 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 quality of product.
- Adapt, maintain, and operate analytical instrumentation.
- Ensure work environment is clean, safe and in compliance with safety and pharmaceutical regulations.
- Conduct radiation safety duties conforming to 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.
Education & Qualifications
- 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 High-Performance Liquid Chromatography (HPLC) and radio-Thin Layer Chromatography (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 demonstrates ability to work easily with cross functional teams.
- Fluent in Microsoft Word and ability to acclimate to new software.
- Strong background in microbiology preferred.
