Olon USA LLC

Job Title: Associate Scientist, QC Essential Responsibilities Perform HPLC, GC, FTIR, KF, DSC, TGA, NMR, etc.Inspect and perform complex chemical analyses on raw materials, in-process samples, and finished goods in accordance with cGMP/GLP standard operating proceduresMay be able to perform routine ICP-MS and ICP-OES analysis for trace metals in a GMP analytical laboratory.Coordinate raw material testing in a materials management systemConduct inspections of manufacturing supplies Conduct inspection of the laboratory or laboratory procedures to ensure conformance to internal quality system or external certification requirements and correct or eliminate process-related non-conformance items.Dispose of expired retained samples and chemicals according to schedules and expiration dates in order to keep lab area clean and safe.Experience with sampling raw materials and intermediatesCoordinate the timely and compliant generation of data to support client projectsReview data for technical content and good record keeping practicesOther duties as assigned Minimal Educational Qualifications B.S. in chemistry with a minimum of 3+ years or M.S with a minimum of 1+ year of related pharmaceutical analytical laboratory experience or equivalent combination of education and experience is required. Relevant experience in good laboratory/manufacturing practices (GLP/cGMP), laboratory quality control or stability, and interaction with quality assurance is required. Specific Skills and Requirements Very strong experience with HPLC and GCExperience with FTIR, TGA, DSC, NMRExperience with XRD, IC, ICP-MS and ICP-OES a plus but not a must.Experience with standard lab equipment (balances, pipettes, pH meter, UV-Vis, etc.) Be proficient in Microsoft Excel and WordMust have basic chemical knowledge and be able to handle materials safely.Must be able to communicate effectively with manufacturing and quality personnel.Must be able to effectively multitask. PI301af0c4f6-

Purpose: Ensure GMP compliance in API Production areas Responsibilities and Duties Review Batch Records directly during production phases Serve as liaison to production operators and shift leaders to provide support and guidance to ensure GMP compliance Communicate with Facility Maintenance team members to understand the control of the production environment during specific events that may impact the quality outcome of API Participate in the initiation or completion of deviations investigations and risk assessments for product quality events to include conducting root cause analysis and performing interviews with appropriate employees Collaborate in the drafting / revision of SOP and MBR, verify correct GMP application and alignment of performed operations with written instructions Review all GMP documentation related to the production area Evaluate change proposals and implementation Verify process documentation Ensure continuous auditing of production areas Oversee correct application of equipment cleaning procedures Review process validation, cleaning validation and equipment / facility qualification protocols Report critical quality situations to supervisors, evaluate solutions and implement directives Propose and monitor implementation and effectiveness of CAPAs related to area of responsibility Support client audits both during on site visits and during drafting of CAPA Plans Required Qualifications Must have direct experience with Quality Assurance within an regulated industry (USDA, FDA, ISO etc) Understands and applies comprehensive knowledge of quality and GMP principles and maintains current understanding of global GMP drug manufacturing regulations BA/BS degree in Science related field or manufacturing is highly preferred, however, strong experience in Quality Assurance in a regulated industry may be considered in absence of a 4 year degree 5 plus years experience as a Quality Professional required PIb8a0ad295e51-7470

Plant Operator (Technician II) OLON USA LLC is seeking qualified candidates to operate chemical process equipment in a pilot plant and laboratory environment. These positions are 12 hours shifts and are available across all shifts. We offer competitive wages, great benefits: 2 medical plans, dental, vision, company-paid life insurance and income continuation plan, supplemental life, 401k with company match 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. Educational Requirements: High school diploma, basic math skills and some knowledge of chemistry Candidates should have mechanical aptitude, demonstrate their strong communication skills and be able to work in a team environment. Must 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 competitive wages along with a comprehensive benefit plan and a great workplace! Olon USA 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. PI5728dea5-