Ohm Labs Jobs in New Jersey
Position Summary Ensure regulatory compliance by providing regulatory support in relation to any field alerts and recalls, withing with the FDA Field offices, evaluating product quality complaints with regards to filing FARS and ensuring compliance with Federal & State regulations. Prove regulatory feedback on manufacturing change controls and ensure any specific commitments filed in regulatory f...
Scope This position supports the regulatory manager in day to day activities to ensure the timely compilation and submission of ANDAs, annual reports, amendments, supplements and deficiency responses to the FDA. Interact and provide support to other departments including, but not limited to, PDTS, Quality Assurance, Quality Control and Manufacturing. Responsible for timely preparation and submis...
· Designs experimental plan; performs pre-formulation, formulation development work and optimize formulation and process by QbD. · Involves in development of product / raw material specifications including evaluation of physicochemical properties and compatibility of raw materials. Reviews analytical data to support the product development work · Plans appropriate analytical testing and stabilit...
Job Description Analyze laboratory samples (raw material, in-process, finished product, stability, etc. Participate in laboratory investigations when required Service laboratory equipment (calibrations, preventative maintenances, etc.) Participates in the development of other Chemists (train, mentor & guide) Comply with all applicable OSHA Safety and Health Programs Adhere to all applicable ...
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