Laboratory/Regulatory Technician

Qualifications: EDUCATION Bachelor’s degree with a major in Science or related field is preferred EXPERIENCE Laboratory experience required, micro analysis preferred. Excellent organization, record keeping and data entry skills required. Good computer skills (Word, Excel. Etc.). Strong written and verbal communication skills Knowledge of the use of pH meters, Brookfield viscometers and laboratory balances, FT-IR, specific gravity, tap density, moisture analyzer, among others is a plus Must be able to differentiate colors Must be able and willing to perform the same types of tasks on a daily basis (for the most, work is routine and repetitive) Understanding of the USP Pharmacopeia is a plus Experience in writing SOP’s is a plus Responsibilities: PRINCIPAL OBJECTIVES Organize, set-up and conduct stability testing of a wide variety of products, in accordance with SOPs and under the supervision and guidance of Director of Regulatory Affairs. Perform Micro analysis to incoming and outgoing product. Prepare stability samples when requested package stability. Maintain testing according to due date and calendar requirements. Update all stability results in laboratory notebook and electronically in a timely manner. Maintain neat, orderly and legible records. Evaluate stability samples and results. Provide data and samples to Director of Regulatory Affairs for review at each time point. Communicate formulation stability results and issues promptly and thoroughly to the responsible Manager (as requested). Assist in the general maintenance and upkeep of Stability laboratory and storage areas. Must be able to write Standard Operating Procedures. Knowledge in USA/EU food, cosmetics and drugs regulations is preferred. Handle other projects and duties as assigned. Interpret test results and investigations. Conduct all activities with high quality, complying with SOPs and cGMP requirements. Assist in the maintenance of laboratory instruments, raw materials, packaging components, glassware, supplies and waste removal. Maintain an organized, clean and tidy laboratory workspace. The worker will also be involved with company certifications agencies. Collect data needed for product registration with federal, state and other regulatory agencies. PHYSICAL REQUIREMENTS: Worker must be able to lift and move objects up to forty pounds as required by laboratory raw material handling and waste disposal practices. Worker is expected to remain standing for sustained periods of time while working at the lab bench and in the laboratory setting. WORKING CONDITIONS: Work is performed in a laboratory and office setting. Worker is not exposed to adverse environmental conditions. The worker will be working with chemicals and expected to wear safety glasses and appropriate personal protective equipment (lab coat, gloves, etc.) and use exhaust hood when needed. The worker is expected to have good lab practices and high regard for safety. COMPENSATION: Competitive Salary PTO Health Insurance 401K Full Time work week schedule : 35 hours a week from 8am until 4pm Job Type: Full-time Pay: $35,000.00 per year Benefits: 401(k) Health insurance Paid time off