Our client, a leading contract development and manufacturing organization (CDMO) based in the US, is seeking a QC Operator to join their growing team. This is a great opportunity to contribute to the development and commercialization efforts.
Title: Quality Control Operator - Night Shift
Salary: $33-$36/hr
Location: Union County, NJ
Contract to hire
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.