- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Job Summary The GMP Quality Assurance Internship is a program that provides training for ... real-world experience into the regulated environment. We are currently seeking a GMP Quality Assurance Intern for the year starting in June 2024. This full-time… more
- Insmed Incorporated (Bridgewater, NJ)
- …York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director Quality GMP Compliance, the Director, Quality Operations will ... QC oversight activities for Insmed. He/she will be responsible for Quality related activities for commercial products including transition from development (Phase… more
- Merck & Co. (Durham, NC)
- …AM - 2:30 PM EST. (May include weekends and holidays)Preferred Experience and Skills: GMP quality experience with biological drug substance or drug product. GMP ... Job DescriptionOur Quality Assurance group ensures all materials inside our...shop floor support in the execution and review of GMP documentation such as IQ, OQ and other technical… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …support, including Service delivery and Incident response) IT Infrastructure SME for Quality assurance / GMP and Validation: Maintain qualified state of ... together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything… more
- Merck & Co. (Durham, NC)
- …our Company, Regulatory Agency, and State and Local code requirements for quality , good manufacturing practices ( GMP ), equal employment opportunity, finances, ... a team of individual contributor production direct reports including safety, quality , and daily operations;Ensure that Shift(s) objectives are achieved while… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Maintenance Technician will maintain facilities, production supporting equipment/systems and quality , in a GMP regulated manufacturing environment, ensuring ... mechanical equipment/systems and production operate efficiently.Job ResponsibilitiesIndependently perform repairs/maintenance of facilities, utilities, and production supporting equipment, while following Standard Operating ProceduresAdherence to Preventive… more
- Merck & Co. (North Wales, PA)
- …areas of expertise.-Provide guidance and coaching to colleagues on New Modalities quality oversight requirements and Health Authority GMP expectations. Required: ... Description: Reporting to the AVP of New Modalities our Manufacturing Division Quality , this leader is responsible for supporting the implementation of a unique… more
- Catalent (Manassas, VA)
- …and follow documents (Standard Operating Procedures and Test Methods); Knowledge of GMP and Quality systems.Basic Microsoft Office (Excel, PowerPoint, and Word) ... Specialist - 2nd Shift is responsible for creating and maintaining the Quality System documentation. Communicate any deviations to management. Assist the Quality… more
- Catalent (Manassas, VA)
- …read and follow documents (Standard Operating Procedures and Test Methods) and Knowledge of GMP and quality systems For business and safety reasons, must be able ... complex formulations to help create engaging new products consumers will love.The Quality Assurance Specialist I - Quarantine is responsible for auditing the… more
- Aequor (Seattle, WA)
- … Training Lead REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities: Must have basic GMP and Quality knowledge. Intermediate skills to navigate a document ... training records are completed per good document principals (GDP). Monitor the Quality Training inbox to provide timely and accurate execution of customer training… more
- Merck & Co. (Millsboro, DE)
- …and state regulatory requirements for animal welfare, management of controlled substances, quality control testing according to GMP standards, and emissions ... (IACUC), and facilitating communication between the Animal Services team and the Quality organization. This position will work in close coordination with other… more
- Catalent (Harman, WV)
- Position Summary The Director, Quality Systems is responsible for the management and oversight of the core quality systems, including investigation/deviation ... management, CAPA tracking, change control, risk management, supplier quality , audits and inspections, raw materials release, and compiling, trending and reporting… more
- Catalent (San Diego, CA)
- Quality Assurance Associate II - Manufacturing Catalent Pharma Solutions in San Diego is currently hiring a Manufacturing Quality Assurance (MQA) Associate II ... of activities pertaining to supporting, maintaining, and assuring compliance with quality systems requirements and applicable regulatory requirements; to advance the… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary:The Quality Engineer will be responsible for providing Quality oversight to the engineering functions at the Company. In this role they assure ... the company's Quality Plan is fully implemented by the engineering department...critical instruments and equipmentProject Management - Assure adherence to GMP requirements in the design, construction, procurement, commissioning, qualification… more
- Catalent (San Diego, CA)
- Quality Assurance Associate I, ManufacturingCatalent Pharma Solutions in San Diego is currently hiring a Quality Assurance Associate I in our QA Manufacturing ... with services that include analytical development, pre-formulation testing, formulation development, GMP manufacturing and stability storage and testing as well as… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Quality Control Associate will serve as a strategic and tactical quality ... ensuring oversight and execution of all aspects of commercial GMP related analytical testing, as well as late stage... related analytical testing, as well as late stage GMP development testing. Responsible for ensuring timely processing of… more
- Catalent (San Diego, CA)
- …primary responsibilities of the Senior QA Manager include activities related to GMP (Good Manufacturing Practices) and regulatory oversight, quality support to ... Senior Manager, Quality AssurancePosition Summary:Catalent Pharma in San Diego, CA...services that include analytical development, pre-formulation testing, formulation development, GMP manufacturing and stability storage and testing as well… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Quality Systems Lead role as part of the Quality Operations team based ... in Raritan, New Jersey. Role Overview The Quality Systems Lead role is an exempt level position...support both clinical and commercial requirements in a sterile GMP environment. This role will serve as the business… more
- Catalent (Philadelphia, PA)
- Job Description Quality Assurance Document Control Position Summary: Catalent Pharma Solutions is Philadelphia, PA is hiring for a Quality Assurance Document ... and approve batch records, and release batch records and finished product. The Quality Assurance Document Control individual acts as the primary liaison to our… more
- Merck & Co. (Rahway, NJ)
- …and Experimentation (FLEx) Center to support drug product development and GMP clinical supply of sterile dosage forms.- Positions will support development ... providing feedback on product and process development.These roles require adherence to GMP procedures, strong attention to detail in completing GMP … more
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