- 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
- 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
- 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
- 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
- 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
- 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
- Quality Chemical Laboratories (Wilmington, NC)
- …work. Candidate must be proficient in Word and formatting documents. Additional quality assurance responsibilities may be required. QCL offers competitive ... Quality Chemical Laboratories (QCL), a leading Pharmaceutical testing...is seeking a qualified candidate for the position of QA Associate - Report Generation. The candidate will be… 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 ... 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. (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
- 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
- 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. (Rahway, NJ)
- …for SDTM Conversions.Demonstrated success in the assurance of deliverable quality and process compliance .Excels in technical writing, able to convert ... process and providing tools and templates to support delivery focusing on traceability, quality assurance , data conformance and data fitness. The position is a… 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 (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 (San Diego, CA)
- …of proteins and antibodies in drug discovery and development, manufacturing, and quality assurance . The Laboratory Support Specialist will provide support both ... help desk and troubleshooting support to customers (in person and remotely)Learn compliance with the USP and EP requirementsSupport the CTI/Repligen Sales Force with… more
- Merck & Co. (Rahway, NJ)
- …performance of team members, fostering a collaborative and innovative team environment.Regulatory Compliance and Quality Assurance :Ensure that all activities ... launch in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Strategic Leadership… more
- Merck & Co. (Durham, NC)
- …Manufacturing Processes, Operations Support, Pharmaceutical Production, Pharmaceutical Quality Assurance , Production Operations, Production Scheduling, ... Safety, Health, Environment and Quality (SHEQ), Safety Procedures, Shift Work, Standards Compliance... Quality (SHEQ), Safety Procedures, Shift Work, Standards Compliance , Systems Troubleshooting {+ 3 more}-Preferred Skills:Job Posting End… more
