- AUROBINDO (Dayton, OH)
- …titrator, Bulk Density, and other routine QC instruments) as per as per USP monograph / In-house / any other Compendial monographs.2. Independently plan and make ... would be preferable Knowledge in Good Documentation practices. Knowledge in USP /ICH/FDA Ability to learn quickly and decision making skillsEducation &… more
- Merck & Co. (Rahway, NJ)
- …to a GLP or regulated laboratory environment as listed in ICH Q2 and USP .Experience with complex glycan analysis and link to mechanisms of actions.Experience in ... analysis of various Biologic modalities (eg, mAb, antibody-drug conjugate, fusion protein).Knowledge and experience in Antibody Drug Conjugate method development.Established scientific reputation supported by publications and external presentations.Strong… more
- Merck & Co. (Rahway, NJ)
- …or regulated laboratory environment as listed in ICH Q2 and USP Excellent track record in scientific publications, patents, or conference presentations.#AR&DCurrent ... Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an… more
- Aequor (Cincinnati, OH)
- …ordering chemicals/materials COMPLIANCE AND QUALITY Basic knowledge and understanding of USP , cGMP, and FDA regulations Create and maintain lab record documentation ... (notebooks and computer based) according to GMPs Demonstrate the philosophy of Right First Time Maintain a clean and safe work environment and follow safety procedures and policies. CONTINUOUS IMPROVEMENT Provide feedback on systems and processes to promote… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the RA CMC representative supporting company initiatives (liaison with PhRMA, USP , ICH, due diligence, regulatory authority inspections). Additionally, this position ... has direct interaction with research laboratory members, the Contract Manufacturing Organization (CMO), Labeling members and Clinical members. This position works with non-standard problems of some complexity. This position makes decisions with consultation.… more
- Optum (Cincinnati, OH)
- …Responsibilities: Perform sterile compounding according to company policy and regulations including USP 797 and USP 800 Maintain competency related to performing ... sterile compounding Participate in medication management for pharmacy compounding, including medication and supply ordering, receiving, and maintenance Troubleshoot equipment, hardware, and software issues relating to compounding. Participate in completing and… more
- Optum (Phoenix, AZ)
- …Responsibilities: Perform sterile compounding according to company policy and regulations including USP 797 and USP 800 Maintain competency related to performing ... sterile compounding Participate in medication management for pharmacy compounding, including medication and supply ordering, receiving, and maintenance Troubleshoot equipment, hardware, and software issues relating to compounding Participate in completing and… more
- United States Pharmacopeia (Rockville, MD)
- Who is USP ? The US Pharmacopeial Convention ( USP ) is an independent scientific organization that collaborates with the world's leading health and science experts ... rigorous quality standards for medicines, dietary supplements, and food ingredients. At USP , we believe that scientific excellence is driven by a commitment to… more
- Lifespan (Providence, RI)
- …Rhode Island Board of Pharmacy Rules and Regulations, United States Pharmacopoeia ( USP ) Chapter <797> Pharmaceutical Compounding - Sterile Preparations, USP ... knowledge of compounding and sterile preparation principles, stability, and compatibility (ie, USP <797> and USP <800>). Maintains working knowledge of and… more
- United States Pharmacopeia (Rockville, MD)
- Who is USP ? The US Pharmacopeial Convention ( USP ) is an independent scientific organization that collaborates with the world's leading health and science experts ... rigorous quality standards for medicines, dietary supplements, and food ingredients. At USP , we believe that scientific excellence is driven by a commitment to… more
- Hims and Hers Health, Inc. (New Albany, OH)
- …and recognized trainer/evaluator, you will assist Supervising Pharmacists ensure compliance with USP 797, 800 (and other applicable chapters) and to compound sterile ... staff in performing sterile compounding activities in compliance with USP 797 and 800 and site SOPs. You will...hire and ongoing sterile compounding and support staff in USP 797 and 800 required core skills, knowledge, and… more
- Hims and Hers Health, Inc. (Gilbert, AZ)
- …compounding environment in conjunction with the maintenance team Follow all safety, USP , BOP, and internal guidelines for the preparation of compounded medications. ... including when working with hazardous chemicals in accordance with USP <800> and applicable laws When required, wear all...laws, policies and procedures that pertain to compounding- specifically USP <795>, <800>, other USP general chapters,… more
- curium (Maryland Heights, MO)
- …international regulatory agencies and guidelines (ie FDA, EU, HC, TGA, PIC/S, ISO, USP , NRC, cGMP, etc.). Ensure all necessary testing is carried out. Approve ... control. Working knowledge of regulatory (FDA, HC, TGA, EU, ISO, USP , etc.) requirements and applicable testing Guidelines. Background must include analytical… more
- Hims and Hers Health, Inc. (New Albany, OH)
- …technician. As part of the pharmacy team , you will use your knowledge of USP 797 to compound medications that are safe and effective for patients, under Pharmacist ... activities according to facility SOPs and as required by USP 797Communicate with pharmacists and report on issues in...instructed by the pharmacist. Completes training as required by USP 797 You Have: Current registration as a Registered… more
- The Pharmacy Hub (Miami Gardens, FL)
- …to produce customized medications safely and efficiently, in full compliance with USP 795, 800 and state board regulations. Key Responsibilities: Inventory Oversight ... storage, and tracking of all materials in accordance with USP and 503A regulations. - Stage ingredients for daily...for hazardous and non-hazardous items - Ensure compliance with USP 800 hazardous drug handling and storage standards (where… more
- Great Bay Staffing Group (Atlanta, GA)
- …as a Director , Manager, or in an equivalent capacity. Strong knowledge of USP , , , DEA, FDA, and applicable state pharmacy board regulations. Demonstrated ... compounding pharmacy, Director of Pharmacy Compliance, pharmacy leadership, pharmacy regulations, USP , USP , USP , SOP development, compounding compliance,… more
- Luminis Health (Annapolis, MD)
- …the inpatient IV rooms and sterile compounding operations, ensuring compliance with USP 797 and 800 standards, aseptic technique, and proper environmental and ... all sterile compounding and handling procedures meet internal protocols, USP 797 and USP 800 requirements, and...procedures meet internal protocols, USP 797 and USP 800 requirements, and applicable regulatory standards. 5. Conducts… more
- Adventist HealthCare (Rockville, MD)
- …a Pharmacy Technician II you will: *Perform sterile compounding according to USP 797 and 800 including electronic documentation *Maintain accurate inventory of ... in a pharmacy specifically using aseptic technique compliant with USP 797 and 800; working knowledge of USP... USP 797 and 800; working knowledge of USP 795. *Preferred: Previous experience with Cerner, Pyxis, Pharmogistics,… more
- Omni Inclusive (Warren, NJ)
- …and local laws. *Ensure compliance with current Good Manufacturing Procedures (cGMP), USP , EU and other global regulatory requirements at all times. *Follow ... strongly preferred *Minimum 4 years of Environmental Monitoring experience *Understand USP , EP, JP, and FDA microbiology testing requirements *Intermediate level… more
- Yoh Services LLC (Noblesville, IN)
- …regulatory agencies and guidelines (ie FDA, EU, HC, TGA, PIC/S, ISO, USP , NRC, cGMP, etc.). Employ aseptic techniques while performing Sterility, Endotoxin, ... testing of drug products, intermediates and raw materials per USP and Curium Standard Operating Procedures (SOP) Perform in...product in support of product efficacy and quality per USP and Curium Standard Test Methods Perform Growth Promotion… more
