OlonRicerca Bioscience

OlonRicerca Bioscience Ohio, USA
Aug 15, 2019
Full time
OLON RICERCA BIOSCIENCE LLC is seeking qualified individuals to operate chemical process equipment in a pilot plant and laboratory environment. Essential Job Functions: This position will involve the operation of chemical process equipment in support of first-time scale-ups, process optimization and small lot production of chemical-based materials in compliance with FDA's current Good Manufacturing Practice guidelines. The successful candidate will execute processing activities according to specific procedures, make observations, record data and maintain accurate documentation. The position is an hourly position. Educational Requirements: High school diploma, basic knowledge of chemistry and math, mechanical aptitude, communication skills and teamwork skills. The position is a 12-hour shift rotation 7 days a week candidate needs to be able to work either shift. Needs to be able to work with and move drum quantities of chemicals. Previous experience, as a chemical plant/pilot plant operator is desirable. Knowledge of chemical hazards, forklift operation and college courses in chemistry considered a plus. We offer a competitive wage along with a comprehensive benefit plan. Come join us! Olon Ricerca Bioscience LLC. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.
OlonRicerca Bioscience Ohio, USA
Aug 15, 2019
Full time
Essential Responsibilities Develop and validate stability-indicating HPLC procedures for small molecule drug substances and drug products. Perform forced degradation studies and develop stability indicating assay and impurities methods Work in a GMP laboratory. Coordinate the timely and compliant generation of data to support client projects. Perform routine HPLC analysis and validation studies Author protocols and reports. Review data for technical content and regulatory compliance. Maintain current expertise with relevant ICH, GMP, and FDA guidelines. Requirements Educational Qualifications B.S. to Ph.D. in chemistry or related field with 5+ years analytical laboratory experience or equivalent combination of education and experience is required. Relevant experience in good manufacturing practices (GMP) laboratory is required. Specific Skills and Requirements Experience in standard lab instrumentation (HPLC, UPLC, etc.) Experience with LCMS or GC preferred but not required Be proficient in LIMS, Microsoft Excel, and Word Must have basic knowledge chemicals their properties, structure, reactivity, and be able to handle with safe and appropriate techniques. Must have basic knowledge of arithmetic, algebra, and statistics. Must be able to communicate effectively with all plant and office personnel. Must be able to effectively multi-task Olon Ricerca Bioscience LLC. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.
OlonRicerca Bioscience Ohio, USA
Aug 15, 2019
Full time
OLON RICERCA BIOSCIENCE LLC is seeking qualified individuals to operate chemical process equipment in a pilot plant and laboratory environment. Essential Job Functions: This position will involve the operation of chemical process equipment in support of first-time scale-ups, process optimization and small lot production of chemical-based materials in compliance with FDA's current Good Manufacturing Practice guidelines. The successful candidate will execute processing activities according to specific procedures, make observations, record data and maintain accurate documentation. The position is an hourly position. Educational Requirements: High school diploma, basic knowledge of chemistry and math, mechanical aptitude, communication skills and teamwork skills. The position is a 12-hour shift rotation 7 days a week candidate needs to be able to work either shift. Needs to be able to work with and move drum quantities of chemicals. Previous experience, as a chemical plant/pilot plant operator is desirable. Knowledge of chemical hazards, forklift operation and college courses in chemistry considered a plus. We offer a competitive wage along with a comprehensive benefit plan. Come join us! Olon Ricerca Bioscience LLC. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.
OlonRicerca Bioscience Ohio, USA
Aug 15, 2019
Full time
Essential Responsibilities Develop and validate stability-indicating HPLC procedures for small molecule drug substances and drug products. Perform forced degradation studies and develop stability indicating assay and impurities methods Work in a GMP laboratory. Coordinate the timely and compliant generation of data to support client projects. Perform routine HPLC analysis and validation studies Author protocols and reports. Review data for technical content and regulatory compliance. Maintain current expertise with relevant ICH, GMP, and FDA guidelines. Requirements Educational Qualifications B.S. to Ph.D. in chemistry or related field with 5+ years analytical laboratory experience or equivalent combination of education and experience is required. Relevant experience in good manufacturing practices (GMP) laboratory is required. Specific Skills and Requirements Experience in standard lab instrumentation (HPLC, UPLC, etc.) Experience with LCMS or GC preferred but not required Be proficient in LIMS, Microsoft Excel, and Word Must have basic knowledge chemicals their properties, structure, reactivity, and be able to handle with safe and appropriate techniques. Must have basic knowledge of arithmetic, algebra, and statistics. Must be able to communicate effectively with all plant and office personnel. Must be able to effectively multi-task Olon Ricerca Bioscience LLC. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.
OlonRicerca Bioscience Ohio, USA
Aug 14, 2019
Full time
Essential Job Functions: Ensure manufacturing and laboratory operations are performed in accordance with cGMPs under ICH Q7 and 21CFR210/211 Conduct in-process inspections of manufacturing and laboratory operations Conduct audits of protocols, Master Batch Records, Production Batch Records, in-process and release laboratory data, cleaning records, test methods, and SOPs Perform internal audits of systems and processes Provide assistance with vendor qualification program and other quality-based systems Educational Requirements: Bachelor's degree in relevant field or Associate's degree with 2-4 years' experience Work Experience/Skills Requirements: Knowledge of auditing techniques Ability to work independently and collectively with diverse groups comprised of chemists, engineers, and technicians Preferred Skills: Experience in quality control Experience with QA GMP manufacturing experience (clinical API manufacturing desired) Knowledge of pharmaceutical principles, practices, and their applications
OlonRicerca Bioscience Ohio, USA
Aug 14, 2019
Full time
Essential Job Functions: Ensure manufacturing and laboratory operations are performed in accordance with cGMPs under ICH Q7 and 21CFR210/211 Conduct in-process inspections of manufacturing and laboratory operations Conduct audits of protocols, Master Batch Records, Production Batch Records, in-process and release laboratory data, cleaning records, test methods, and SOPs Perform internal audits of systems and processes Provide assistance with vendor qualification program and other quality-based systems Educational Requirements: Bachelor's degree in relevant field or Associate's degree with 2-4 years' experience Work Experience/Skills Requirements: Knowledge of auditing techniques Ability to work independently and collectively with diverse groups comprised of chemists, engineers, and technicians Preferred Skills: Experience in quality control Experience with QA GMP manufacturing experience (clinical API manufacturing desired) Knowledge of pharmaceutical principles, practices, and their applications