Chemist III

Job Qualifications:

• BS in Chemistry / Biochemistry
• Minimum 5-8+ years in FDA regulated environment working in QC laboratory.
• A foundation in analytical technique, with hands-on sample preparation and operation of analytical equipment and software required.
• Proficiency in analytical techniques such as HPLC, GC, FTIR, UV-Vis, and wet chemistry methods.
• Strong knowledge of GMP, GLP, and regulatory requirements (e.g., FDA, ICH guidelines).
• Excellent data analysis, problem-solving, and troubleshooting skills.
• Experience with laboratory information management systems (LIMS) is preferred.
• Experience with raw material, stability, in-process, and finished product testing.
• Experience with data analysis (MS Excel) and proficiency with MS Word required.
• Strong organizational, communication, and interpersonal skills.
• Attention to detail and a commitment to producing accurate, high-quality results.
• Ability to work independently and as part of a team in a fast-paced environment.
• Adaptability to changing priorities and deadlines.
• Strong analytical and critical thinking skills.
• Demonstrate good laboratory practices.
• Participate in research and development projects
• Good oral and written communication skills.
• Flexible availability.

POSITION RESPONSIBILITIES:

• Perform analysis in the functional areas of analytical testing using modern analytical equipment such as HPLC, FTIR, UV, GC, ICP, as well as Wet Chemistry using titration techniques.
• Perform troubleshooting and maintenance on critical lab instruments (HPLC, GC, ICP, etc.)
• Provide analytical testing in support of production, analyzes Raw Material, In-Process, Finished product, Stability samples and investigation samples and analyzes and interprets the test data and document result in a timely manner.
• Thorough understanding and compliance with FDA cGMPs / cGLPs / USP / ICH / SOPs / Test Methods and other recognized standards.
• Support and be the lead in Analytical and Chemical test method development and test method validations as necessary.
• Writing of SOPs, test methods, study protocols, reports and reviews.
• Training of lab analysts on analytical test method procedures and usage of equipment and documentation.
• Share in the responsibilities of housekeeping (i.e. glassware, waste, retains, lab waste disposal, etc.).
• Communicate lab test data, data review, and reporting of OOS / QR / OOT test results to the lab manager.
• Provide ideas/feedback for areas where efficiency can be implemented in the lab through the 5S process improvement program.
• Support all general safety, and pharmaceutical compliance requirements
• Coordinate with calibration services in the upkeep of lab instrumentation
• Initiate and complete analytical test methods associated with raw materials, finished products, and lab instrumentation.
• Mentor other chemists in the QC laboratory
• Lead laboratory investigation efforts and draft final reports for review by management
• Assist with annual management review metrics for QC laboratory functions.

PHYSICAL REQUIREMENTS:

• Employees are required to wear eye protection and lab coats while in the lab
• Work safely and follow all OSHA regulations and company safety policies and procedures.
• Ability to frequently lift and/or move up to 25 lb.
• Ability to occasionally lift and/or move up to 35 lb.
• Ability to regularly stand, sit and walk to perform tasks.