QC Chemist Laboratory Union County , NJ, US + Added - 23/09/2024 Apply for Job _Our client, a leading contract development and manufacturing organization (CDMO) based in the US, is seeking a QC Chemist to join their growing team. This is a great opportunity to contribute to the development and commercialization efforts._ **Job Type:** Full time **Location** : Union County, NJ **Responsibilities:** + Perform QC stability testing, and prepare and maintain stability records and summaries + Develop, train, and transfer methods to and from QC and contract manufacturers as assigned. Modify and validate analytical procedures to meet QC needs + Design and develop experimental protocols, SOPs, etc., consistent with cGMP/GLP. Conduct all QC chemical tests required for batch release for patient use + Participate in and lead special projects and department meetings, providing input, feedback, and executing assigned tasks + Solve analytical and instrument problems through special projects + Perform timely QC of radioactive and microbiological products and record quality + Operate, maintain, and adapt analytical instrumentation + Ensure the work environment is clean, safe, and compliant with safety and pharmaceutical regulations + Perform radiation safety duties in accordance with regulations + Report monthly on QC supply orders involving devices and reagents + Contribute to industrial and R&D qualification and validation activities and support routine maintenance + Lead laboratory investigations and root cause analyses + Prepare chemical reagents for manufacturing and QC **Qualifications:** + Bachelor’s degree in chemistry or Biochemistry, with a minimum of 3 years of applicable GMP laboratory experience required + Radiopharmaceutical experience preferred. Proficiency in 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, with the ability to work under strict timelines + Ability to convey complex ideas simply to management and customers, exercising independent judgment during method development/transfer processes + Knowledge of analytical methods currently used for testing, release, and stability of sterile pharmaceutical products + Team oriented mindset with the ability to work effectively with cross-functional teams + Proficiency in Microsoft Word and experience with laboratory information management systems (LIMS) INDBH LIDNP We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.