- The US Pharmacopeial Convention (USP) (Rockville, MD)
- **Description** ** Pharmaceutical Product Quality Testing (PPQT) Market and Demand Generation Consultancy** The **U.S. Pharmacopeial Convention (USP)** is ... that enable a resilient supply of high- quality medical products. USP's Pharmaceutical Product Quality Testing (PPQT) program is a voluntary… more
- Charles River Laboratories (Rockville, MD)
- …Demonstrates knowledge and understanding of pharmaceutical manufacturing and quality assurance, aseptic and packaging processes, and product transfer. ... fields. Minimum 5 years of experience in GMP related experience in biopharmaceutical/ pharmaceutical Strong knowledge of GMP, SOPs and quality system processes.… more
- Cardinal Health (Annapolis, MD)
- …leaders. + Conducts product pilot tests, customer trials, focus groups, and other product concept testing to gather customer feedback and to determine the ... Health Sonexus (TM) Access and Patient Support helps specialty pharmaceutical manufacturers remove barriers to care so that patients...remain on the therapy they need for a better quality of life. Our diverse expertise in pharma, payer… more
- Charles River Laboratories (Rockville, MD)
- …Production Records (BPRs) and associated supporting documentation including logbooks, Quality Control (QC) testing reports, environmental monitoring reports, ... about. **Job Summary** This leadership role is responsible for a team of Quality Operations Specialists, which will require providing oversight of quality … more
- Sumitomo Pharma (Annapolis, MD)
- …activities including, but not limited to deviations, investigations, metrics and product quality complaints. Partners with internal stakeholders to ensure ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma… more
- Catalent Pharma Solutions (Harmans, MD)
- The **Manager, Quality Systems Audit** is responsible for the management and oversight of the core quality systems related to Supplier Quality Management, ... This role is also responsible for compiling, trending and reporting key Supplier Quality metrics for Senior Leadership review. This role may also engage on all… more
- Charles River Laboratories (Rockville, MD)
- …of master/working cell banks, bulk drug substance, plasmid products and/or final drug product used for human consumption * Support Manufacturing and quality ... deviations and failure investigations, including root cause analysis, evaluating product /facility impacts, and identifying/implementing effective corrective and preventive actions… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …support low-carbon active pharmaceutical ingredient (API) and finished pharmaceutical product manufacturing. + Conduct climate vulnerability assessments for ... with the world's leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. At USP, we… more
- Charles River Laboratories (Hanover, MD)
- …and appropriately document all Receipt (incoming) and Shipment (outgoing) of materials, documents, testing samples and product for the facility. + Create and ... for Charles River, your role involves efficiently managing materials to support testing and meet client demands. Responsible for updating the Supply Chain Database… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …preferably in the pharmaceutical industry or a contract lab that does testing for pharmaceutical industry or other evidence of experience in conducting ... with the world's leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. At USP, we… more
- Sumitomo Pharma (Annapolis, MD)
- …Information (USPI), European Summary of Product Characteristics (SmPC), and Canadian Product Monograph (PM) + Ensures timely and quality review and ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma… more
- Catalent Pharma Solutions (Harmans, MD)
- …and process improvement. + Assist in the preparation and review of annual product quality reviews and regulatory compliance reports. + Monitor and ensure ... service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience… more
- Sumitomo Pharma (Annapolis, MD)
- …of SOPs, business rules and training + In depth knowledge of pharmaceutical manufacturer compliance, patient confidentiality, product reimbursement and ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations...support program & HUB operations supporting the rare disease product (s). The Director leads the design and execution of… more
- Sumitomo Pharma (Annapolis, MD)
- Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma ... Duties and Responsibilities** + Defines submission outlines, content, format, and quality requirements for electronic submissions. + Manages the tracking, compiling,… more
- Sumitomo Pharma (Annapolis, MD)
- Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma ... and maintenance of PV staff learning plans, assisting with compliance activities, quality monitoring, management of the CTSA mailbox, and is the PVRM Team… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …to ensure that surveillance audits/internal audits and surveillance documentation review and product testing are conducted according to program requirements. + ... activities related to current Good Manufacturing Practice (cGMP) site audits, quality control and manufacturing (QCM) product documentation reviews, and… more
- Catalent Pharma Solutions (Harmans, MD)
- …for client projects. + Provide quality oversight in compliance with GMPs for Quality Control testing of clinical product . + Support the Investigation and ... or Biotech field with 4 - 6 years' experience Quality Assurance/ Quality Control function reviewing Analytical testing data for analytical assays such… more
- Catalent Pharma Solutions (Harmans, MD)
- The **Manager, Sterility Assurance,** will be responsible for quality assurance oversight of Aseptic Processing Program, Environmental Monitoring and Microbial ... Control Policies for Gene Therapy Drug Substance and Drug Product Operations. This individual should be able to work independently with little direction to develop… more
- Sanofi Group (Baltimore, MD)
- …Responsibilities:** + Grow portfolio share and revenue and to consistently deliver on product goals. + Be a therapeutic area expert, with the ability to position ... identifying key opportunities and developing strategic business plans to generate product utilization and grow territory business. + Understand and differentiate… more
- Sumitomo Pharma (Annapolis, MD)
- Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma ... of the cross-functional teams from preclinical experiments to the end of the product 's life cycle. + Clinical Trial Oversight: Develop and oversee clinical trial… more