- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. SummaryThis is a global role that is responsible for QA GMP activities pertinent to the overall compliance state of DS drug substance, drug ... marketed globally and acts as a global partner to successful drive QA GMP deliverables as appropriate. This position has a global responsibility to effectively drive… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary The GMP Quality Assurance Internship is a program that provides training for the ... will allow them to dive into different functions of GMP QA Department such as Audit, Quality Management System,...into the regulated environment. We are currently seeking a GMP Quality Assurance Intern for the year starting in… more
- Merck & Co. (Rahway, NJ)
- …Small Scale Organics (SSO) Pilot Plant is a Good Manufacturing Practices ( GMP ) facility within the Process Research and Development (PR&D) organization which enables ... operations, process development activities, compliance investigations/change management, authoring of GMP documentation, and lead other staff in the pilot plant… more
- Merck & Co. (Rahway, NJ)
- …(small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned in Rahway, New Jersey. ... operations, process development activities, support compliance investigations/change management, author GMP documentation and manage/lead engineers in any of our… more
- Aequor (Thousand Oaks, CA)
- …remote Shift/Schedule: 8:00 -4:30 pm (flex) -Monday - Friday **Candidates must have GMP and pharmaceutical experience** What you will do Let's do this! Let's change ... as a subject matter expert of clinical and commercial product stability studies and GMP data management. In this team-based role, you will directly add to the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. Job Summary:Accountable to manage and oversee QA GMP activities pertinent to commercial and Investigational Medicinal Products (IMP) to ... incumbent is responsible to adhere and maintain Quality Management System and GMP Compliance Programs to assure product quality, integrity and compliance with… more
- Merck & Co. (Rahway, NJ)
- …Small Scale Organics (SSO) Pilot Plant is a Good Manufacturing Practices ( GMP ) facility within the Process Research and Development (PR&D) organization, which ... assists on daily production activities while ensuring compliance with Safety, GMP , and Environmental requirements in addition to the existing labor contract… more
- Merck & Co. (Durham, NC)
- …activities are carried out in accordance with established safety, GMP , and calibration/maintenance procedures.Facilitates contractors by obtaining bids, review ... refrigeration systems).Working knowledge of regulatory requirements in accordance with GMP manufacturing operations.Willing and able to lift 50 pounds, climb… more
- Aequor (South San Francisco, CA)
- …various solutions, buffers, clean glassware and prepared equipment for use throughout GMP and/or R&D groups. Preparation of stock such as reagents, buffers, ... various solutions, buffers, clean glassware and prepared equipment for use throughout GMP and/or R&D groups. Preparation of stock such as reagents, buffers,… more
- Merck & Co. (Rahway, NJ)
- …maintenance and calibration data build, as well as other GMP operational readiness critical activities to enable facility startup.Post turn-over ... from project, it will be to maintain all equipment in accordance with GMP and Safety requirements, as well as exercising Reliability Maintenance best practices to… more
- Merck & Co. (Rahway, NJ)
- …Research Laboratories, our company's Manufacturing Division, Animal Health and GWES. The system is GMP and monitors areas and equipment that are both GMP and ... and the ability to understand, update and implement changes to the GMP system.Ability to problem solve/troubleshoot, with knowledge of root cause analysis.Experience… more
- Merck & Co. (Rahway, NJ)
- …(small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned in Rahway, New Jersey. ... activities, compliance investigation, change management and the authoring of GMP documentation in any of our enabling facilities.Additional Supported AreasAs… more
- Aequor (Thousand Oaks, CA)
- …a regulated environment (eg cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, deviations, corrective and preventative ... and qualifications/validation. Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as cell culture… more
- Catalent (St. Petersburg, FL)
- …as assigned.The CandidateBS in scientific field with 7+ years' experience in lab, 3 in GMP orMS in scientific field with 5+ years' experience in GMP lab or ... Doctorate in scientific field with 3+ years' experience in GMP labExperience with UV spectroscopy, IR and AA instrumentation, HP LC. and GC instrumentation and… more
- Catalent (Harman, WV)
- …vision and direction for materials handling and distribution.Ensure that all activities follow GMP regulations.Ensure that all project work is managed under GMP ... into timelines.Ensure proper methodology is used for project delivery and compliance ( GMP , GLP, SOX) requirements are met. The candidate: Bachelor's Degree in… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Small Scale Organics (SSO) Pilot Plant is a GMP (Good Manufacturing Practices) manufacturing facility in the Small Molecule Process Research and ... gain of critical internal experience with scale-up of manufacturing GMP steps, demonstration of new manufacturing technology/processes, training opportunities for… more
- Merck & Co. (Durham, NC)
- …lyophilizers, etc.).Provide QA shop floor support in the execution and review of GMP documentation such as IQ, OQ and other technical documents to meet schedule ... 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 … more
- Merck & Co. (Durham, NC)
- …Electronics, or Electrical Working knowledge of regulatory requirements in accordance with GMP manufacturing operations Experience working in a clean room or GMP ... troubleshooting experience with automated process equipment in the biopharmaceutical field GMP compliant maintenance database systems Knowledge of SAP, Delta V and… more
- Merck & Co. (Durham, NC)
- …equipment maintenance, electrical and instrument calibration.Experience with GMP -compliant calibration and/or maintenance database systems.Preferred Experience and ... maintenance and familiarity with regulatory requirements in accordance with GMP manufacturing operations Operation, maintenance, and/or troubleshooting experience with… more
- Merck & Co. (Durham, NC)
- …shutdown execution including all maintenance, calibration, capital project work, and GMP Cleaning coordination for all facility shutdownsCoordinates with Durham Site ... time management skillsWorking knowledge regulatory requirements in accordance with GMP manufacturing operationsGood oral and written communication skillsProject management,… more
