- Jungle Jim's Pharmacy (Fairfield, OH)
- …of batch records, compounding logs, and other documentation required for regulatory compliance . Equipment Operation and Maintenance: Operate and maintain ... stock and conduct periodic inventory audits to prevent expired medications and ensure compliance with regulatory requirements. Compliance and Regulatory … more
- Careers Integrated Resources Inc (Round Lake, IL)
- …solutions when issues arise. . Maintain and meet the highest standards in quality, customer service and regulatory compliance . . Other projects as assigned. ... The Position encompasses the biological, chemical and physical analyses on pharmaceutical products (biologics and drugs) through all stages of the manufacturing… more
- DivIHN Integration Inc (Round Lake, IL)
- …Maintain and meet the highest standards in quality, customer service, and regulatory compliance . Other projects as assigned. Qualifications: Knowledge of Empower ... The Position encompasses the biological, chemical, and physical analyses of pharmaceutical products (biologics and drugs) through all stages of the manufacturing… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …and management of continuous improvements, training and best practices to ensure regulatory compliance and consistency for Takeda Patient Access programs. ... my knowledge. **Job Description** **About the role:** You will lead compliance activities including process development, audits and inspections for Patient Access.… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …duties as required + Support all cross functional teams within the site for document control related needs + Support regulatory inspections and audits + Maintain ... Quality Assurance Specialist, Document Control Department: QA Manufacturing Location: Monroe, NC START YOUR APPLICATION… more
- Amneal Pharmaceuticals (Branchburg, NJ)
- …Department and training records. + Perform data entry and management in systems ( Document Compliance and Process Compliance ) and maintain the print/soft ... Description: The document control specialist is responsible for administering the...for administering the processes and practices which support documentation compliance . The Specialist will work in a pharmaceutical… more
- Takeda Pharmaceuticals (Columbus, OH)
- …book roundtables, drafting regulatory notifications, coordinating and managing regulatory document workflows, inputting information into regulatory ... colleagues. + Significant experience in global drug development regulations, regulatory submissions, lifecycle management, compliance , business systems… more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- …Coordinates document requests and stages documents for presentation during regulatory inspections + Implements and maintains document repositories and ... manufacturing documentation and supporting documentation + Investigates and leads compliance items for department This role may be for...may be for you if you: . Have previous document control experience in the pharmaceutical industry.… more
- Dana-Farber Cancer Institute (Boston, MA)
- … compliance for entire portfolio. Implements systems to monitor and ensure regulatory document collection and maintenance compliance . + Assumes ... study group registrar and pharmaceutical company as outlined in protocol. ** Regulatory & Compliance ** + Assumes responsibility for essential document … more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …will be responsible for supporting the Process Sciences, Manufacturing, and CMC Regulatory Departments through compliance activities and documentation related to ... Regeneron is looking for a Compliance Specialist to join our Process Sciences Change...Regeneron has successfully commercialized numerous products. Gaining approval from regulatory agencies is dependent on demonstrating that our processes… more
- Takeda Pharmaceuticals (Boston, MA)
- …with computer applications and understanding of safety data. + Knowledge of pharmaceutical business, including drug development and regulatory aspects. + ... planning, preparation and submission of high- quality aggregate safety reports, in compliance with requisite global and local regulations and requirements. As part… more
- Takeda Pharmaceuticals (Lexington, MA)
- …state of compliance . + Knowledgeable in local, state, and federal regulatory requirements and proposed regulatory or legislative changes at all levels. ... operations or changes that result in EHS impacts. + Identify and document unsafe work conditions, support investigations of incidents and identification of… more
- University of Pennsylvania (Philadelphia, PA)
- …and annual reports, development/maintenance of study-specific case report forms and source document tools, provide direct regulatory / compliance guidance, and ... The Clinical Research Regulatory Specialist position will assist in maintaining regulatory compliance for the Department of Otorhinolaryngology. The RAS will… more
- Takeda Pharmaceuticals (Thousand Oaks, CA)
- …and forms for accuracy and agreement to global procedures based on regulatory requirements and internal guidelines, etc. + Escalate and communicate ambiguous ... years of experience in quality operations and/or equivalent years in biotechnology, pharmaceutical , or a similar GMP manufacturing environment would be ideal. +… more
- Takeda Pharmaceuticals (Los Angeles, CA)
- …Interpret and evaluate issues for acceptability to standards, procedures and regulatory requirements. Help document issues with immediate corrections and ... for Teardown, Fractionation, and Purification observing cGMP, GDDP, FDA and Regulatory Standards, ISO requirements, and internal standard operating procedures. You… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …has authored and published in medical/scientific peer-reviewed journals. Interactions with Regulatory agencies or Common Technical Document (CTD or "dossier") ... We are seeking a qualified physician scientist with significant pharmaceutical /biotechnology sector and/or exceptional academic clinical trials' experience. With… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Global Clinical Supply Chain Operations. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led ... of clinical trial material for shipment to sites. + Interface with the Pharmaceutical Sciences group to ensure that trial supplies are appropriately supported with… more
- Takeda Pharmaceuticals (Columbus, OH)
- …outcomes. + Contribute to maximizing clinical trial delivery process efficiency and regulatory compliance by identifying opportunities for innovation as it ... is required. + Knowledge of clinical trial management and/or GCP compliance processes. + Comprehensive knowledge of regulatory requirements governing… more
- Catalent Pharma Solutions (Bloomington, IN)
- …maintenance and support of enterprise systems in accordance to company policy and regulatory compliance + Document requirements, defines scope, define ... high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new...in a GxP environment while following company policies and regulatory compliance . This position will work with… more
- Mallinckrodt Pharmaceuticals (Fenton, MO)
- …validation. ESSENTIAL FUNCTIONS: Execute batch record review and document deficienciesIdentify exceptions and report exceptionsResolve documentation discrepancies ... Root Cause Analysis teamsFollow all internal and basic cGMP guidelines for pharmaceutical operationsAdhere to all safety rules and maintain 100% completion of all… more
