Under general supervision, performs maintenance and calibration of analytical instruments and equipment. Assists with qualifying equipment and instruments. Repairs analytical instruments and equipment. Assists with general support of lab functions. Essential functions include:*Carries out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws.
*Calibrations and maintenance on lab instruments and equipment.
*Repair of lab instruments and equipment.
*Operates general analytical instruments: HPLC, Gas Chromatography (GC), UV, automatic titrator, IR, AA, and dissolution.
*Labels, transcribes and records documentation such as report sheets and laboratory notebooks as required by Standard Operating Procedures (SOPs).
*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.
Two (2) years related laboratory experience, or an equivalent combination of education and experience. Knowledge of:*Pertinent SOP's related to pharmaceutical laboratory testing, analyses and documentation.
*UV/IR, HPLC, GC and dissolution instruments operation methods and techniques.
*Business, scientific and personal computer hardware and software applications.
*Business English usage, spelling, grammar and punctuation.
*Chemistry related to standard preparation, quality control systems, analysis and documentation practices and procedures.
*FDA, cGLP, cGMP, and SOP regulatory rules, regulations and guidelines.
*Spectroscopic and chromatographic operation, techniques and systems.
*Current Company policies, practices and procedures, including safety rules and regulations.
*Being mechanically inclined – working hands on with scientific instruments and equipment.
*Analytical mechanical troubleshooting.
*Performing testing accurately and precisely.
*Responding to routine inquiries from management, employees and regulatory agencies.
*Communicating clearly and concisely, both orally and in writing.
*Analyzing problems, identifying solutions, and recommending alternate solutions.
*Operating scientific and personal computers.
*Managing multiple projects, duties and assignments.
*Establishing and maintaining cooperative working relationships with others.
*Complying with all Company policies and procedures, including safety rules and regulations.
Bachelor’s Degree in Science or related science field from an accredited college or university.