- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... difference? The Position Position is responsible for developing Quality and USO strategic objectives and strong business understanding of the value chain and… more
- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is ... to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company...delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and in a manner which meets their expectations Coordinates and collaborates with Quality Assurance function to maintain a COE for deviation management covering ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....customer focus. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements in relation… more
- Repligen (Waltham, MA)
- …the biotechnology industry. This leader will be responsible for managing the site quality assurance team which includes all day-to-day activities for product ... meetings with the Senior Management team.Facilitate operational excellence initiatives in Quality Assurance .Maintain internal and external audit schedules; serve… more
- Merck & Co. (Durham, NC)
- …Processes, Operations Support, Pharmaceutical Production, Pharmaceutical Quality Assurance , Production Operations, Production Scheduling, Safety, Health , ... 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 ... the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality...3 floating holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and… more
- Merck & Co. (Rahway, NJ)
- …process and providing tools and templates to support delivery focusing on traceability, quality assurance , data conformance and data fitness. The position is a ... health .Responsibilities: The Senior Statistical Programmer, Submission Data Standards Quality Management (SDS QM), provides oversight and quality management… more
- Eisai, Inc (Raleigh, NC)
- …Eisai Raleigh facility. This position is responsible for executing core quality assurance functions, supporting regulatory inspections, and collaborating with ... of combination products and/or Biologics is a plus). Demonstrated experience across applicable quality assurance functions in a GMP setting (eg, batch record… more
- Repligen (Hopkinton, IA)
- …and make real-time adjustments to meet production targets.Inspect products for quality assurance and report defects or inconsistencies.Communicate effectively ... will play a key role in ensuring that the department's safety, quality , and production goals are met.ResponsibilitiesSupervise and coordinate the activities of… more
- Repligen (Hopkinton, IA)
- …use of basic Microsoft Office tools (Outlook, Excel, Word)Minimum 0-2 years' experience in Quality Assurance in an ISO 9001 certified Quality Management ... seeking a QC Inspector I to join our growing Quality Department team in Hopkinton, MA for 2nd shift...non-contributory pension, generous PTO, partial compensation on your personal health insurance and flexible working hours. But most importantly… more
- Tris Pharma (Monmouth Junction, NJ)
- …coordinates and advances required documentations, in liaison with Product Development (PD)/ Quality Assurance (QA)/ Quality Control (QC)/Regulatory Affairs, ... (FDA), Drug Enforcement Administration (DEA) and Occupational Safety and Health Administration (OSHA) regulations and guidancesThorough knowledge of MV parameters… more
- Twist BioScience (South San Francisco, CA)
- …MES professionals, primarily software developers, who work in concert with Manufacturing Operations, Quality Assurance , and R&D. The Director will serve as the ... closely with the platform architecture and infrastructure teams, Manufacturing Operations, Quality Assurance , Process Development, and Regulatory Affairs teams… more
- Repligen (San Diego, CA)
- …of proteins and antibodies in drug discovery and development, manufacturing, and quality assurance . The Laboratory Support Specialist will provide support both ... trusted partner in the production of biologic drugs that improve human health worldwide. Focused on cost and process efficiencies, we deliver innovative technologies… 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
- 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...3 floating holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and… more
- Merck & Co. (North Wales, PA)
- …management conceptsExperience in CDISC and ADaM standardsDemonstrated success in the assurance of deliverable quality and process compliance.Strategic thinking - ... drugs and vaccines for the benefit of patients and global human health .This position supports statistical programming activities for multiple and/or late stage… more
- AUROBINDO (Durham, NC)
- …family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In ... with benefits administration including medical, dental, vision, COBRA and 401(k), health and welfare open enrollment, and wellness program initiatives.Assist with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Confirm final profile and submit in Zycus for SAP creation.As relevant, liaise with the Quality Assurance group to obtain QA risk rating and audit status for RDP ... up-to-date evaluations. Review and update questions and pending statuses with the Quality Assurance group on a regular basis.Qualifications Successful candidates… more
- Merck & Co. (Upper Gwynedd, PA)
- …related pharmaceutical operations (eg, manufacturing, formulation and process development, analytical, quality assurance , n ovel modality and technologies such ... IND/CTA, original NDA/MAA, agency background packages and responses to health authority questions per established business processes and systems.-Identify,… more
