- ABM Industries (Oceanside, CA)
- Overview Job Summary Details: The GMP (Good Manufacturing Practices) Cleaner plays a critical role in maintaining cleanliness and hygiene standards within the ... experience Preferred Qualifications: Previous experience in cleaning within a GMP -regulated environment, preferably in the pharmaceutical or healthcare industry.… more
- Otsuka America Pharmaceutical Inc. (Richmond, VA)
- Job Summary The Associate Director, Global Product Quality - GMP Process is responsible for enabling the optimization and harmonization of key GMP quality ... leadership, coaching, and subject matter expertise to global teams on GMP compliance and quality system execution. Qualifications Required Bachelor's degree in… more
- United Therapeutics (Durham, NC)
- …you'll feel right at home here. How you'll contribute The Senior GMP Maintenance Technician (DPI) executes planned and unplanned maintenance and repairs on ... manufacturing, filling, assembly and packing/kitting lines to ensure the efficient production and supply of Tyvaso DPI medicine. This role works closely with the Lead Mechanic to ensure (a) timely completion of maintenance events, (b) documentation of events… more
- Sanofi Group (Framingham, MA)
- …In-depth knowledge of regulatory requirements and Good Manufacturing Practices ( GMP ) relevant to sterility assurance and microbiological control Communication skills ... to communicate with a large number of functions (from shopfloor to management) and to present complex subjects Ability to organize and lead routine investigations with a multi-disciplinary team Special Working Conditions Ability to gown and gain entry to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Summary: Accountable to organize and directs an audit universe for GMP relevant activities involving but not limited to supplier qualification program, ... CMC audit, clinical/IMP vendor audits and overall GMP vendor audit program. Establish lessons learned from audits/inspections...lead and or co lead due- diligence assessments of GMP facilities and or CMOs as deemed necessary. Ensure… more
- Merck & Co. (Rahway, NJ)
- …both in terms of facility construction and organizational realization. The GMP facility is designed for multi-product operations with flexible operating suites, ... new technologies, trialing new automation strategies, and implementing them in the GMP areasSupport capital projects, work to design, install, and qualify new… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Quality Associate Director/ GMP Lead Site Auditor will have leadership responsibility for the site internal audit program, encompassing the full ... years of manufacturing, technology, laboratory, and/or quality operations experience within GMP environment GMP Compliance knowledge and proficiency in… more
- Bristol Myers Squibb (Indianapolis, IN)
- …Engineer will lead validation efforts to support the Radiopharmaceutical facility and GMP operations in Indianapolis. This role is responsible for the development, ... seamless progression from construction to clinical development and commercial GMP operations. Responsibilities include onboarding advanced technologies (such as… more
- Otsuka America Pharmaceutical Inc. (Phoenix, AZ)
- …way that is in accordance with regulatory expectations and applicable GMP /GDP quality standards. This role will provide specialized Biologics Quality Assurance ... and downstream biologics manufacturing processes, ensuring compliance with biologics-specific GMP requirements. This role has global responsibility for managing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …facility to support both clinical and commercial requirements in a sterile GMP environment. This role will ensure compliance within the document management system, ... for procedures.Issuance of batch related documentation in support of GMP manufacturing.Reconcile GMP documentation following document lifecycle… more
- Cleveland Clinic (Cleveland, OH)
- …In this role, you will apply your expertise in Good Manufacturing Practice ( GMP ) and biotherapeutics to support the production and release of investigational cell ... who excels in this role will Serve as a subject matter expert, using GMP and biotherapeutics expertise to contribute to the production and release of investigational… more
- Merck (West Point, PA)
- …The Process Operations Specialist is responsible for leading and executing GMP bioreactor operations in support of clinical manufacturing campaigns, ensuring ... to deliver high-quality, compliant biomanufacturing operations. Key Responsibilities: Execute GMP batch records for upstream bioreactor operations across scales… more
- System One (Indianapolis, IN)
- …organization provides central execution support in onboarding suppliers, materials, and GMP service providers in a timely manner to support project timelines ... focus is to provide a globally holistic process in which GMP supplier and GMP service provider's Supplier Quality Management activities are globally consistent,… more
- Fujifilm (Thousand Oaks, CA)
- …for guiding the Manufacturing Team in the execution of clinical and commercial GMP cell therapy activities. These include media preparation, master cell banks, viral ... activities in an aseptic environment, ensuring adherence to schedules and GMP compliance Operations Management: Assist in daily manufacturing operations, identify… more
- Merck & Co. (Durham, NC)
- …Experience and SkillsMinimum two (2) years post-bachelor's degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations ... Collaborative Communications, Corrective Action Management, Data Analysis, Equipment Troubleshooting, GMP Compliance, Good Manufacturing Practices ( GMP ), Hardware… more
- United Therapeutics (Durham, NC)
- …take pride in ensuring accuracy, compliance, and quality at every step-from receiving GMP materials to shipping finished products. With a keen eye for improvement ... Supervisor, Dry Powder Inhalation (DPI) is responsible for overseeing incoming GMP material receipts, expensed supplies and material receipts, control and issuance… more
- ValSource, Inc. (Worcester, MA)
- …technically skilled leaders in Process/Process Equipment Engineering to support exciting GMP Drug Substance and Drug Product capital projects throughout our network ... support our clients’ Process Engineering programs within Pharmaceutical and Biotech GMP manufacturing facilities. This includes systems and equipment used in these… more
- ValSource, Inc. (Durham, NC)
- …commissioning, qualification, validation (CQV) of Pharmaceutical and Biotech GMP manufacturing facility systems and equipment. Responsibilities are expected ... US and international regulations (FDA, ICH, ISO, EU) for validation of GMP facilities. Proficiency with Microsoft office including Word, Excel, and PowerPoint.… more
- ValSource, Inc. (Rahway, NJ)
- …exciting projects with our clients in the pharmaceutical and biotech and related GMP manufacturing industries throughout each of our regions in the US. The ... and equipment qualification activities, and ensuring compliance with FDA, GMP , and other regulatory requirements. ResponsibilitiesOn-Site Project Management: Interface… more
- Cipla (Hauppauge, NY)
- …and conducting quality inspections. The role also ensures adherence to GMP and GDP standards, handles non-conformance issues, supports supplier management, and ... findings. Ensure all warehouse operations comply with Good Manufacturing Practices ( GMP ) and regulatory requirements. Participate in internal audits and ensure… more
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