- Merck & Co. (Rahway, NJ)
- …Management Process, Manufacturing Processes, Manufacturing Quality Control, Process Improvements, Quality Assurance ( QA ), Quality Assurance ... include but are not limited to the following: Perform quality assurance activities related to API manufacturing...compliance with cGMP and regulatory filings. Perform independent quality review and approval of batch records, testing data,… more
- Aequor (Thousand Oaks, CA)
- …industry experience will not be considered. This position supports 's Quality Assurance program under the Plant QA organization providing daily oversight of ... compliance issues, providing recommendations, and assuring progress of quality records to completion. The Sr. Associate will also...will also represent functional area for the Drug Substance Quality Assurance department in the execution of… more
- Insmed Incorporated (San Diego, CA)
- …of Clinical Quality Assurance (CQA) serves as a strategic leader managing quality and regulatory compliance related to GCPs, acts as quality lead on ... for potential use and provides direction, guidance and strategy for company Quality Assurance .Full understanding of and practical experience establishing 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 ... delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and...Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ensuring highest quality to patients. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements in relation to ... applicable Develops comprehensive, relevant resources (eg training program, FAQs) to enable compliance with quality control process requirements across NNI and… more
- Eisai, Inc (Raleigh, NC)
- …Eisai Raleigh facility. This position is responsible for executing core quality assurance functions, supporting regulatory inspections, and collaborating with ... Specialist plays a critical role in ensuring the quality and compliance of commercial and clinical...and/or Biologics is a plus). Demonstrated experience across applicable quality assurance functions in a GMP setting… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance , clinical quality , ... Biotech is seeking QA Validation Specialist III as part of the Quality team based in Raritan, NJ. Role OverviewThe QA Validation Specialist role… more
- Repligen (Hopkinton, IA)
- OverviewWe are seeking a Document Control/ QA Associate I to join our growing Quality Department team in Hopkinton, MA for 1st shift operations (M-F) from 8 am ... EST - 4:30 pm EST.The Document Control/ QA Associate I will report directly to the ...responsible to actively participate in the Repligen ISO 9001 Quality Management System. This role is responsible for assisting… more
- Tris Pharma (Monmouth Junction, NJ)
- …coordinates and advances required documentations, in liaison with Product Development (PD)/ Quality Assurance ( QA )/ Quality Control (QC)/Regulatory ... required documentations and change control activities, in liaison with PD/ QA /QC/Regulatory AffairsDesigns experimental plans; Critically analyzes data and information… more
- Merck & Co. (Rahway, NJ)
- …IT Business Solutions, Management Process, Management System Development, Problem Management, Quality Assurance ( QA ), Resource Planning, Service Delivery, ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more
- BioAgilytix (Durham, NC)
- …with hands-on responsibility for data quality , access control, and compliance protocols.Define standards, build quality assurance processes, and ... a focus on operational efficiency and data integrity. Data Quality & Compliance Automation: Use Robotic Process...systems.Proven ability to define data standards, develop and implement quality assurance processes, and ensure data integrity… more
- Repligen (Waltham, MA)
- …issues through appropriate channels, ensuring long-term risk mitigation and product quality assurance .Qualifications Bachelor's degree in engineering, Quality ... team. You will a key role in ensuring the quality , compliance , and performance of Repligen's global...in supplier quality engineering, manufacturing engineering, or quality assurance . Proven experience with ISO 9001… 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
- 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
- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThe Manager Audits & Compliance , GCP/Document Audits supports end-to-end audit activities per audit program of ... provide inspection management support and follow-up activities post inspection regarding compliance commitments are fulfilled on time and that evidence is… more
- Merck & Co. (Rahway, NJ)
- …Mechanical Apptitude, Pharmaceutical Development, Pharmaceutical Manufacturing, Pharmaceutical Quality Assurance , Process Technologies, Production Efficiencies, ... will provide hands on assistance for daily production activities while ensuring compliance with Safety & Environmental (S&E) and current Good Manufacturing Practices… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …while ensuring alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This ... applications meet strict regulatory requirements, industry best practices, and internal quality standards. The Lead is responsible for defining and driving the… 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....chain and customer focus. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements… more
- Merck & Co. (Durham, NC)
- … compliance goals through a risk-based approach (Safety Regulations, Quality Assurance , Risk Management, Deviation Management, Product Release, Change ... 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
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