- Olema Oncology (San Francisco, CA)
- …longer. For more information, visit us at www.olema.com. About the Role Associate Director, GMP Quality Assurance As the Associate Director, GMP Quality ... Agreements with the company's Contract Service Providers Develop, track, and trend GMP Quality Metrics for product quality and compliance Partner with GCP … more
- Merck & Co. (Rahway, NJ)
- …data analytics/visualization software . - Familiarity with Good Manufacturing Practices ( GMP ) requirements, quality procedures, and Standard Operating Procedure ... a lead GCS Planning program representative ) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines ,- strategies and… 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
- The Facilities Group (Summit, NJ)
- … quality . What you'll be doing: We are looking for a responsible and quality -driven GMP Cleaner to join our team. You will be responsible for supporting ... strong organizational skills, and pride in delivering excellent service. GMP Cleaner Responsibilities: Follow all Standard Operating Procedures (SOPs) Performs… more
- Merck & Co. (Rahway, NJ)
- …formulation and process development through process tech transfer, scale-up activities, quality investigations, change management, and authoring GMP standard ... molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice ( GMP ) clinical supply manufacturing facility in Rahway, New Jersey.The Sterile… more
- Twist BioScience (South San Francisco, CA)
- …Operations/QCPreferred QualificationsKnowledge of/experience with Quality Control and Quality Assurance principles, including GMP /ISOKnowledge of molecular ... He/she will work closely with the operations team to monitor the quality of Twist DNA products utilizing quantitative measurements, fragment analysis, NGS… more
- Aequor (Thousand Oaks, CA)
- …management when appropriate. Reviewing protocols for manufacturing activities and partnering with Quality Assurance to ensure that GMP standards are maintained ... to add value to the network: Manufacturing, Process Development, Supply Chain, Quality , and Facilities & Engineering. A high degree of interactions and collaboration… more
- Eisai, Inc (Raleigh, NC)
- …of combination products and/or Biologics is a plus). Demonstrated experience across applicable quality assurance functions in a GMP setting (eg, batch record ... hear from you. The QA Specialist plays a critical role in ensuring the quality and compliance of commercial and clinical products manufactured at the Eisai Raleigh… more
- Merck & Co. (Rahway, NJ)
- …and reports to the Sterile Pharm Ops Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical Supply (PSCS)The FLEx sterile facility ... Sterile2).Primary responsibility will be to maintain all equipment in accordance with GMP and Safety requirements, as well as exercising Reliability Maintenance best… more
- Merck & Co. (Rahway, NJ)
- …of the integrated US Metrology and Validation team and drive a culture of quality and operational excellence across the global AR&D network. The role oversees and ... and routine maintenance of analytical equipment and instrumentation within the GMP environment.The key responsibilities of this role will include:Partner with… more
- Aequor (Thousand Oaks, CA)
- …f will have 1-2&plus years of hands-on experience in a regulated GMP environment, preferably within the pharmaceutical, biotech, or food industries. While a ... experience is more important. Candidates should be familiar with manufacturing or quality operations and understand the pace and expectations of a high-volume,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in Raritan, ... Lead role is an exempt level position with responsibilities for supporting the quality systems processes within a cell therapy manufacturing facility to support both… 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)
- …equipment troubleshooting? We're looking for a dedicated professional to ensure top-notch quality , on-time delivery, and seamless operations in a dynamic GMP ... service. Demonstrates ability to meet customer expectations in term of quality /quantity and on-time delivery as appropriate.Oversee and maintain schedule adherence… more
- Merck & Co. (Durham, NC)
- …Durham sites.- This includes Energy Center, Vaccines Manufacturing and Bulk Facilities, Quality Labs, and Maintenance and Material Storage Facility (MMSF). At times, ... maintenance activities are completed in accordance with established safety, GMP , and calibration/maintenance proceduresUpdate maintenance procedures to ensure work… more
- Aequor (Thousand Oaks, CA)
- …weighing, titration, and pH measurement, and be comfortable working in a GMP -regulated environment. Experience with chromatography or protein handling is a plus, but ... not required, as full training will be provided. Strong attention to detail, good documentation practices (GDocP), and comfort with lab notebooks and SI pages are essential.Job Details: Under general supervision, this position will perform routine procedures… 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)
- …make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant ... connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates, and finished products.The Sr. Specialist, Calibration… more
- Merck & Co. (Durham, NC)
- …sites.- This includes Energy Center, Vaccine Bulk and Manufacturing Facilities, Quality Labs, Material Management Storage Facility (MMSF) and projects. At times, ... and approve out of tolerance (OOT) records and ensure quality notifications follow when required.Facilitate scheduling of calibration activities with… more
- Merck & Co. (Durham, NC)
- …data collection techniques, and troubleshooting in compliance with SDLC, GMP , safety, and environmental regulations.- Actively support, participate and embrace ... an empowered team culture including significant interaction with manufacturing, quality and engineering groups.- Supports a spectrum of sophisticated automated… more
