QUALITY CONTROL CHEMIST I in SOMERSET, New Jersey at ASPIRE PHARMACEUTICALS INC

Position Summary:

The Quality Control Chemist-I is responsible for conducting routine testing and analysis of raw materials, in-process materials, and finished product samples using various analytical methodologies to ensure the quality of dietary supplements and OTC products. This role includes reviewing and maintaining Standard Operating Procedures (SOPs), Testing Procedures, calibrations, and other controlled documents to ensure compliance with regulatory standards and internal procedures. Additionally, the Chemist-I will assist in quality control stability testing and contribute to maintaining accurate records and documentation.

DUTIES AND RESPONSIBILITIES:

• Ensure all work is performed in compliance with cGMP, GLP, compendia standards, and internal procedures.
• Conduct wet chemistry and analytical testing on raw materials, finished products, in-process samples, stability, and packaged products according to Testing Procedures.
• Assist in quality control stability testing, prepare, and maintain stability records and summaries.
• Operate, maintain, and troubleshoot analytical instruments, including pH meter, FTIR, TOC, UV, and others as necessary.
• Maintain accurate records of all analyses, ensuring contemporaneous documentation and adherence to company standards.
• Perform laboratory analysis right the first time and ensure all results are properly documented.
• Conduct laboratory investigations under the guidance of laboratory management.
• Work effectively under the direction of supervisors and/or manager, and perform additional duties as required.

QUALIFICATION AND EXPERIENCE:

• Bachelor’s degree in chemistry, Biochemistry, Pharmaceutical Sciences, or related field with 0 - 3 years of relevant experience in a quality control setting; or an equivalent combination of education and experience.
• Basic understanding of Current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and quality control principles in the pharmaceutical industry.
• Math skills commensurate with a scientific background are required.
• Ability to communicate test results and observations clearly, both verbally and in writing.
• Ability to follow written instructions and solve basic analytical problems using standard procedures.