Quality Control Analyst Job at Tri Pac, Inc. in South Bend

The Quality Control Analyst collaborates with team members to ensure all products meet customer and FDA regulations with regards to personal care products including topical, oral, aerosols, hair care, cosmetics and OTC products, as well as testing of products and packaging. He/she consults with the Validation Department on measuring equipment and can recognize hazardous chemicals and follows protocol for handling the materials and proper disposal procedures. The Sr Quality Analyst is detail oriented and understands the importance of following GMP and FDA procedures for hazardous chemicals. Responsibilities: Qualitative and Quantitative testing of propellants, liquids, products and impurities. USP Testing Protocols. Growth by design through innovation and trends. Experience working in a regulated environment (GMP/GDP, 21 CFR 210/211/820/700-740, ISO 13485). Expertise and subject matter expert in technical aspects and troubleshooting of raw materials in creams, liquids, gels and pastes. Experience in lab, pilots, and scale ups. Collaborative approach with validation and engineering teams. Documentation and recording techniques per GLP, GDP and GMP guidelines. Conducts and tracks all required performance and stability tests, interprets, records and reports results. Use of Statistical Analysis of instrument capabilities to set Instrument Specification & selection for analytical process, IQ/OQ/PQ of equipment. Metrology, troubleshooting, preventative maintenance of simpler lab equipment (pH meters, customer level PM for GC’s, FTIR, viscometers, piston pipettes, etc.) and arranging for repairs and PM for lab equipment (e.g. viscometers, GC, LC, FTIR, etc.). Wet Chemistry Method Development, Validation of GC methods. Statistical Evaluation of methods to ensure they are capable of meeting consistent accuracy & precision requirements. Lab Manager Tasks: ordering lab supplies, inventory chemicals, & disposal of Lab wastes. Write Procedures: SOP’s, Protocols for Validation, Validation reports, OOS, CAPAs, etc. Perform Assay Validations. Knowledge of USP Monographs. Writing & Validating Spreadsheets for Data Calculation. Self-motivated, highly structured, communicates effectively, and detail oriented. Awareness of chemical hygiene. Education and/or Experience: Bachelor of Science in Chemistry or related discipline required with a min 5-7 years’ experience in analyzing raw materials and products with experience in aerosols, foams, and BOV technologies. Master of Science degree in related discipline preferred. In depth knowledge of principles of OTC, medical devices, and consumer products Ability to formulate and test product formulations. Knowledge of lab Instrumentation including GC, HPLC, FTIR, GMP, GLP, GDP, LIMS Statistical Evaluation of Assay capability (f-tests, power tables, confidence intervals. FMEA, User Requirement Specifications, and Change Control experience. Experience working