- 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 ... Eisai Raleigh facility. This position is responsible for executing core quality assurance functions, supporting regulatory inspections, and collaborating with… more
- Aequor (Thousand Oaks, CA)
- …to management when appropriate. Reviewing protocols for manufacturing activities and partnering with Quality Assurance to ensure that GMP standards are ... to add value to the network: Manufacturing, Process Development, Supply Chain, Quality , and Facilities & Engineering. A high degree of interactions and collaboration… more
- Twist BioScience (South San Francisco, CA)
- …in Operations/QCPreferred QualificationsKnowledge of/experience with Quality Control and Quality Assurance principles, including GMP /ISOKnowledge of ... 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)
- …graduates without industry experience will not be considered. This position supports 's Quality Assurance program under the Plant QA organization providing daily ... have 1-2&plus years of hands-on experience in a regulated GMP environment, preferably within the pharmaceutical, biotech, or food...will also represent functional area for the Drug Substance Quality Assurance department in the execution of… more
- Aequor (Thousand Oaks, CA)
- …also acceptable. A bachelor's degree is preferred but not required. Previous experience with GMP is a plus but not mandatory, as training can be provided. The role ... sampling and inspection of raw materials and components and for performing Quality review of documentation for assigned functions (eg equipment and maintenance… more
- Repligen (Waltham, MA)
- …issues through appropriate channels, ensuring long-term risk mitigation and product quality assurance .Qualifications Bachelor's degree in engineering, Quality ... 5+ years of experience in supplier quality engineering, manufacturing engineering, or quality assurance . Proven experience with ISO 9001 audits and supplier … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell ... the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality...support both clinical and commercial requirements in a sterile GMP environment. This role will serve as the business… more
- Merck & Co. (Rahway, NJ)
- …Mechanical Apptitude, Pharmaceutical Development, Pharmaceutical Manufacturing, Pharmaceutical Quality Assurance , Process Technologies, Production Efficiencies, ... Job DescriptionThe Small-Scale Organics (SSO) Pilot Plant is a GMP (Good Manufacturing Practices) manufacturing facility in the Small Molecule Process Research and… more
- Merck & Co. (Durham, NC)
- …Manufacturing Processes, Operations Support, Pharmaceutical Production, Pharmaceutical Quality Assurance , Production Operations, Production Scheduling, ... 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… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell ... seeking QA Validation Specialist III as part of the Quality team based in Raritan, NJ. Role OverviewThe QA...support both clinical and commercial requirements in a sterile GMP environment. This role will also provide oversight of… more
- Aequor (Houston, TX)
- …and knowledge with others across the team o Routine interaction with Quality Assurance (Raw Materials) and other interdepartmental members to communicate ... systems, and demonstrates ability to read and comprehend GMP documents (ie SOPs, logs, Batch Records) o Problem...to work well within a team. Routine interaction with Quality Assurance and other Quality … more
- Merck & Co. (Rahway, NJ)
- …IT Business Solutions, Management Process, Management System Development, Problem Management, Quality Assurance (QA), Resource Planning, Service Delivery, SLA ... improvement opportunities, and develop unbiased tangible and intangible value realized.Understanding of GMP with a strong motivation to build deep expertise in CMC… more
- Insmed Incorporated (San Diego, CA)
- …strategies.Facilitate collaboration with both internal and external drug substance analytical, quality control, quality assurance , and manufacturing ... participate in the process execution within a Pilot Plant non- GMP manufacturing environment.Review batch records, SOPs, raw material specifications, protocols… more
- Eisai, Inc (Exton, PA)
- …will collaborate effectively with other Development groups as well as with Facilities, Quality Assurance , Quality Control, Regulatory, and CMC Program ... Interact cross-functionally with Support Services, Facilities, Biologics Process Development, Quality Assurance , Quality Control, Validation, and… more
- Merck & Co. (Durham, NC)
- …Compliance:-Achieve compliance goals through a risk-based approach (Safety Regulations, Quality Assurance , Risk Management, Deviation Management, Product ... Biologic, and Vaccine Products. Our team works with a "Safety First, Quality Always" mindset.-As the primary point of contact for all dealings between… more
- Actalent (Birmingham, AL)
- … GMP monitoring of laboratories, manufacturing areas, and warehouse facilities. Skills quality assurance , gmp , quality control, chemistry, sap, ... quality management system Top Skills Details quality assurance , gmp , quality control,chemistry,sap, quality management system Additional Skills &… more
- Catalent Pharma Solutions (Kansas City, MO)
- …+ High School Diploma required with at least one year of experience in Manufacturing/ Quality Assurance in a GMP manufacturing environment. Will also accept ... **Associate, Quality Assurance ** **Position Summary:** Catalent, Inc....oversight of manufacturing "floor" activities and the associated in-process GMP (Good Manufacturing Practices) records. In addition to day-to-day… more
- Actalent (Madison, WI)
- …log books. + Issue batch records as needed. Essential Skills + Quality assurance expertise. + FDA and GMP compliance knowledge. + Experience with batch ... Technician **3rd Shift: 4pm to 4am** Job Description The Quality Assurance Tech plays a crucial role...+ 2+ years of experience in a regulated industry ( GMP /FDA/ISO). + For Sr. roles, 5+ years of regulated… more
- Nitto Denko Corp. (Milford, MA)
- …in Chemistry, Biology, Pharmaceutical Sciences, or related discipline. + 5+ years in GMP Quality Assurance within the pharmaceutical or biotech industry. ... About this opportunity : The Senior Quality Systems Specialist, QA will be responsible for...of Change Controls, Deviations, CAPAs, Batch Records, and associated GMP documentation to ensure compliance with applicable regulatory standards… more
- Actalent (Des Moines, IA)
- …with company standards and policies. Essential Skills + Proficiency in Chemistry, HPLC, GC, GMP , Quality Assurance , and Quality Control. + Experience ... Quality Assurance Technician Job Description We are seeking dedicated Quality Assurance Technicians to join our dynamic team in Des Moines. As a QA… more
