- Insmed Incorporated (NJ)
- …degree (MS, PhD, PharmD) strongly preferred.Minimum of 15 years of relevant Quality Assurance experience in the biopharmaceutical industry, including at least ... in technical development activities, including process development, method validation /transfer, formulation work, and scale-up.Drive phase-appropriate quality … 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 ... release goals. Be able to perform all IPQA (In-Process Quality Assurance ) functions during IPQA absences.ResponsibilitiesCoordinate production priorities.Review… more
- Insmed Incorporated (NJ)
- …Bridgewater, NJ or San Diego location. The Sr. Quality Engineer, Digital Systems Quality Assurance ( QA ), is responsible for providing quality ... Computer Science, Engineering, or related field preferred.5+ years of experience in Quality Assurance , Validation , within the FDA-regulated pharmaceutical or… 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 ... responsible for design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and… more
- BioAgilytix (Durham, NC)
- …for data quality , access control, and compliance protocols.Define standards, build quality assurance processes, and monitor data integrity to meet regulatory ... LIMS and ERP systems.Proven ability to define data standards, develop and implement quality assurance processes, and ensure data integrity in alignment with… more
- Aequor (Davie, FL)
- …and qualified equipment parameters (QEPs) assessment, CPPs and CQAs identified during pre- validation work. Participation in internal (Corporate and QA audits) ... and process confirmation studies in coordination with planning, manufacturing, quality , LTS and PM groups. Review and analysis of...of the analytical and statistical data to support the pre- validation work. Analysis of data to ascertain the data… more
- Merck & Co. (Rahway, NJ)
- …with internal stakeholders and partners such as Chemical Engineering, Process Chemistry, Quality Assurance and pilot plant support staff.Support internal and ... testing through active collaboration with cross-functional project teams and/or Quality stakeholders. Identify appropriate corrective and preventative actions.Document the… more
- Merck & Co. (Rahway, NJ)
- …advisor for all teams working on Autoinjectors, fostering collaboration among engineering, quality assurance , regulatory, and manufacturing teams across the CMC ... Manufacturing divisions.Interface with external suppliers and partners to ensure the quality and compliance of components used in Autoinjectors, driving performance,… more
- Merck & Co. (Rahway, NJ)
- …and Effect Analysis (FMEA, DFMEA). Liaises closely with other partner functions including QA ( Quality ), Analytical Sciences, CROs and others to support project ... Engineering, Mechanical Testing, Medical Devices, Medical Devices Design, Method Validation , Microscopies, Product Development, Project Leadership, Prototyping, Quality… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …with other functions including but not limited to Tech Support, Process Improvement, Validation , Supply Chain, Operations, QA , Reg CMC, and IT. This individual ... updates with other Supply Chain Systems (ERP, eLIMs, etc.).Support MES validation activities according to the Software Development Lifecycle (eg commissioning test… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …priorities of the MES organization. Role will work collaboratively with Operations, IT QA , Validation , Reg CMC to deliver on-time, on-budget and right-first-time ... with multiple organization particularly investigations, manufacturing, technical support and QA .Ensure MES team can prioritize and manage multiple tasks… more
- Han IT Staffing Corporation (New York, NY)
- …ideas and plans to both technical and non-technical stakeholders. * Collaborate with QA teams to ensure thorough testing and validation of developed solutions. ... project requirements, and develop solutions that meet business needs. * Write high- quality , maintainable, and efficient Java code, adhering to industry standards and… more
- AJA Video Systems, Inc. (Grass Valley, CA)
- The Quality Assurance ( QA ) Manager will oversee the activity of the quality assurance department and staff, developing, implementing, and maintaining ... and track key performance indicators (KPIs) to assess product quality and QA process effectiveness. + Generate...quality considerations are incorporated. + Hire and train quality assurance staff. + Oversee the daily… more
- Astellas Pharma (Westborough, MA)
- ** Validation Lead, Quality Assurance ** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are ... research programs. AIRM is headquartered in Massachusetts. Astellas is announcing a ** Validation Lead, Quality Assurance ** opportunity at their **Astellas… more
- Astellas Pharma (Sanford, NC)
- …. The **Specialist, QA Validation ** is responsible for providing quality assurance oversight and support for the commissioning, qualification, and ... **Specialist, QA Validation (Onsite in Sanford, NC)**...current Good Manufacturing Practices (cGMP), regulatory requirements, and internal quality standards. The position collaborates cross-functionally with Validation… more
- Curia (Rensselaer, NY)
- …assistance to Engineering Services, R&D, Production, Maintenance and QA /QC in Validation and Quality Assurance -related issues. This role serves as ... Senior QA Validation Specialist - CSV Systems...Senior QA Validation Specialist - CSV Systems Engineer Summary: The...concepts and approaches with audits and inspections + Provide Quality validation review and approval through the… more
- Pfizer (Sanford, NC)
- …suggest improvements and conducts continuous improvement activities + Represent QA Validation in cross-departmental/cross-site meetings + Maintain oversight ... Will Achieve** In this role, you will: + Review validation documentation for the site, (including but not limited...application process and/or interviewing. Requests for any other reason will not be returned. Quality Assurance and… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- Our QA Fill Finish Validation team is hiring a Principal QA Validation Specialist to validate and qualify equipment, systems, and processes in compliance ... Chemistry, or Life Sciences and the following years experience for each level: + QA Validation Specialist: 2+ years + Sr QA Validation Specialist: 5+… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- Our Fill Finish QA Validation team is hiring. As the Senior QA Validation Specialist, you will ensure equipment, systems, and processes meet regulatory ... Chemistry, or Life Sciences and the following years experience for each level: + QA Validation Specialist: 2+ years + Sr QA Validation Specialist: 5+… more
- Development InfoStructure (Washington, DC)
- …This role requires comprehensive expertise in data platform testing, security compliance validation , and federal quality assurance standards to ensure ... for all solutions and documentation Data Quality Assurance + Implement database testing and SQL validation... quality status reports + Develop and maintain quality metrics and KPI reporting Agile QA … more
