The opportunity
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, UPLC, GC-FID, UV-VIS, FTIR, automatic titrators, Dissolution Apparatus, particle size analyzer, Instron, Densitometer, Rheometer, viscometer (LV/RV/Cone and Plate), pH meter and analytical balance.
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 related duties as assigned.
Your experience and qualifications
Education/Certification/Experience
Bachelor’s Degree required, preferably in Science or related science field from an accredited college or university and minimum of one (1) year experience required in related laboratory experience
Skills/Knowledge/Abilities
Usage of GC and HPLC chromatographic equipment, as well as UV/VIS, dissolution apparatuses, FTIR, Instron operation and other techniques in testing gels, creams, lotions, oral solutions and transdermal system.
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, USP, EP 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.
