Under general supervision, performs cGMP laboratory analyses of Finished products and in process materials. Performs stability testing for Finished products. Performs maintenance and calibration of analytical instruments. Essential functions include:
*Carries out responsibilities in accordance with the organization?s policies, procedures and state, federal and local laws.·
*Operates general analytical instruments during the testing of finished products using HPLC, GC-FID, UV-VIS, FTIR, automatic titrators,
*Performs Instron and viscosity testing.
*Performs wet chemistry tests on samples such as pH, and titration and prepares standard, sample, and buffer solutions as required by test methods and performs all necessary calculations associated.
*Labels, transcribes and records documentation such as report sheets and laboratory notebooks as required by SOPs.
*Cleans, maintains and calibrates laboratory equipment to ensure compliance with current Good Manufacturing Procedures (cGMP).
*Meets project deadlines and performance standards as assigned.
*Complies with all Company policies and procedures, including safety rules and regulations
*Performs investigations and troubleshooting of analytical test methods and lab instruments.
*Carries out quantitative and qualitative analyses in support of method comparisons, method transfers and method validations.
*Performs related duties as assigned.
One (1) year related laboratory experience or an equivalent combination of education and experience.
Experience and Skills:
-Usage of GC and HPLC chromatographic equipment, as well as UV/VIS, and FTIR operation methods and techniques.
-Business, scientific and personal computer hardware and software applications.
-Business English usage, spelling, grammar and punctuation.
-Wet Chemistry and Chemistry related to sampling methods, quality control systems, analysis and documentation practices and procedures.
-Knowledge of or ability to learn FDA, cGLP, cGMP, and SOP or other applicable regulatory and safety compliance guidelines.
-Performing testing accurately and precisely.
-Responding to routine inquiries from management, employees and regulatory agencies.
-Communicating clearly and concisely, both orally and in writing.
-Managing multiple projects, duties and assignments.
-Establishing and maintaining cooperative working relationships with others.
NOTE: Position not eligible for relocation benefit. ***
Bachelor's Degree in Science or related science field from an accredited college or university.