Description

You will serve as a dedicated data reviewer for the Chemical Quality Lab, focusing on physical and dimensional testing data.

Responsibilities

• Review analytical data from wet chemical techniques and instrumental analyses including titration, pH measurements, AA, HPLC, GC, and UV/Vis.
• Perform calculations, prepare solutions, and enter results into the LIMS system in accordance with cGMPs.
• Monitor laboratory metrics related to turnaround goals.
• Ensure lab safety and compliance with DEA, FDA, OSHA, and ICH guidelines.
• Prioritize data review and testing workflows based on guidance from the Data Coordinator or supervisor.

Required Skills

• Bachelor of Science in a Life Science (e.g., Chemistry, Biology, or Microbiology).
• Minimum of 5 years of experience in a Quality Control or R&D laboratory.
• At least 1 year of specific data review experience within a pharmaceutical manufacturing environment.
• 4-5 years of experience reading and interpreting chromatographic data.
• Hands-on experience with HPLC, GC, and AA/ICP-MS.
• Working knowledge of cGMPs and international regulatory standards.
• Proficiency in recording and processing data according to FDA and ICH guidelines.

Preferred Skills

• Experience with Empower3 and LIMS.
• Experience with biological techniques such as BET, antibiotic potency, or sterility testing.

Key Skills

Education

Bachelor's degree