- BioAgilytix (Durham, NC)
- …a foundational data governance framework, with hands-on responsibility for data quality , access control, and compliance protocols.Define standards, build ... meet regulatory requirements, including HIPAA, GxP, GDPR, and FIRPA.Design data quality KPIs and implement initial ...status, religion, age, disability, gender identity, results of genetic testing , service in the military, or any other group… more
- Aequor (Thousand Oaks, CA)
- …requirements, associated with biologics and synthetic chemical manufacturing and QC testing . Previous experience using VEEVA, Trackwise and quality systems. ... of biopharmaceutical bulk and drug product development, manufacturing, and/or Quality Control Testing . As a Product ...Specialist will be encouraged to use technical abilities to lead and deliver quality assurance responsibilities while… more
- BioAgilytix (Durham, NC)
- …life-changing, life-saving therapeutics to the patients who need them.The Cybersecurity Lead will be responsible for building and leading BioAgilytix's global ... security posture across a multi-site, regulated CRO environment. The Cybersecurity Lead will unify existing policies into a streamlined, risk-based framework, ensure… more
- Merck & Co. (Rahway, NJ)
- …degree of technical, project, and people management responsibility. - This SSO Facility Lead role within the SSO Pilot Plant leverages significant depth and breadth ... of scientific, technical, and operational experience to lead and support facility operations, process development activities, compliance investigations/change… more
- Aequor (Cincinnati, OH)
- …sampling, food safety physical and documentation audits, and finished product pathogen testing . Like all Quality department professionals at , this position ... Job Title: Food - Quality Technician Location: Cincinnati, OH 45241 Duration: 03... notifications in SAP for defective materials or packaging Lead the plant sensory program, documentation, and gold standard… more
- Insmed Incorporated (NJ)
- …provide strategic and technical oversight for laboratory operations, including routine testing , data review, investigations, and documentation. The individual ... and driving operational excellence within QC functions. A deep understanding of GMP, quality control processes, and analytical testing for inhalation products is… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Manufacturing Lead Operator as part of the Technical Operations team based in Raritan, ... scheduled tasks within a CGMP environment. This position is responsible for quality and maintaining the highest standards in compliance within company policies,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAre you enthusiastic and driven to create and lead execution of design verification testing strategies for innovative combination products?Join ... at the device component/ subassembly/ in-process material and combination product level. Lead stablishing test methodologies/ testing readiness and execution in… more
- Merck & Co. (Rahway, NJ)
- …stakeholders and partners including Quality , Pipeline, and Operations.Supervise microbiology testing , data entry, data review, and author /approve ... of microbiology laboratory practices and procedures in a GMP environment including microbiology data review and quality procedures.This position is based at the… more
- Insmed Incorporated (NJ)
- …through Phase 3, ensuring compliance with GMPs and internal standards.Serve as the Quality lead for GMP activities supporting clinical trial materials, including ... Establish QA-QA relationships and checkpoints for critical CDMOs and service providers. Lead or support Quality Agreements, risk assessments, audits, and… more
- Merck & Co. (Rahway, NJ)
- …internal stakeholders and partners including Quality , Pipeline, and Operations.Perform microbiology testing and studies, data entry, data review, and ... of microbiology laboratory practices and procedures in a GMP environment including microbiology data review and quality procedures. This position is based at the… more
- Aequor (Vacaville, CA)
- …mature, maintain, and retire SAP Master Data Objects related to Production and Quality Data . This includes, but is not limited to Material Masters, Recipes, ... for all SAP attributes of the site Product and Quality Master Data Management throughout the ...Support local/global SAP projects; participate in site user acceptance testing ; provide user requirements review and input. Proactively identify… more
- Insmed Incorporated (San Diego, CA)
- …development and implementation of EDC systems to support clinical trials, ensuring data quality , compliance, and efficiency throughout the study lifecycle. The ... Are you?About the Role:The Associate Director, EDC Programming will lead and oversee EDC programming, and database build for...with GCP, 21 CFR Part 11, and CDISC ODM Standards. Data Quality & Compliance: Ensure EDC systems… more
- Merck & Co. (Rahway, NJ)
- …and execution, along with leadership skills to shape the technical capabilities lead a global, cross-modality technical team.The Associate Director will lead ... activities for shock and vibration as well as thermal protection system testing and qualification and leading execution of qualification of complex systems.-The… more
- Merck & Co. (Rahway, NJ)
- …Change Management, Combination Products, Compliance Packaging, Cross-Cultural Awareness, Data -Driven Decision Making, Design Verification Testing , Distribution ... strategic direction for a global, cross-modality technical team. The Director will lead a team of technical experts responsible providing Logistics and Distribution… more
- Merck & Co. (Rahway, NJ)
- …Products, Compliance Packaging, Continual Improvement Process, Cross-Cultural Awareness, Data -Driven Decision Making, Design Verification Testing , Driving ... and strategic direction for a global, cross-modality technical team. The Director will lead a team of technical experts responsible for technical leadership of key… more
- Merck & Co. (Rahway, NJ)
- …- Background in Analytical Methodologies and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and ... the group Director to define group strategy and to lead a team of scientists in solving complex analytical...and qualification of release, characterization, and stability assays for testing of clinical trial material and in support of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …not limited to Operations, MSAT, Facilities, C&Q, Project Management, and Quality .Work closely with Sr. Manager, Strategic Initiatives to support various strategic ... efficient, and compliant manner.Participate in Risk Assessments, FMEAs, and system/ data process mapping activities.Execute, own, assess and participate in the… more
- Rocket Lab Corporation (Long Beach, CA)
- …a clean sheet development of re-usable liquid launch vehicle, this is your opportunity! QUALITY ENGINEERING LEAD - ENGINES Based out of Rocket Lab's headquarters ... in Long Beach, CA the Quality Engineering Lead - Engines is responsible... engineer in aerospace or spacecraft manufacturing environment. Hands-on quality and testing experience. Strong Knowledge of… more
- Coinbase (Charlotte, NC)
- …Operations function efficiently, comply with regulatory requirements, and consistently deliver high- quality resolutions. As a Lead Analyst, Compliance EDD ... Crime Risk Service line and support functions to maintain production and quality of the highest standard. You will work independently, prioritizing multiple tasks… more
