- Legend Biotech USA, Inc. (Raritan, NJ)
- …team setting with quality counterparts that include Quality Assurance , Manufacturing Operations, and Analytical/Process Development. RequirementsA minimum of ... a Bachelor's Degree in Science, Engineering or equivalent technical discipline is required.A Minimum of 4 years relevant work experience, preferably within a biological and/or pharmaceutical industry is required.Experience in a Quality Control setting is… more
- Cipla (Hauppauge, NY)
- …or biological sciences. 2+ years of experience in validation, and quality assurance in Pharmaceutical field 1+ years of direct experience in the Equipment ... validation/qualification, utility and facility qualifications Hands on experience working with GAMP 5 systems and 21 CFR Part 11 compliance. Demonstrated ability to interpret and apply pharmaceutical industry regulatory compliance requirements with an emphasis… more
- Merck & Co. (Rahway, NJ)
- …conceptsExperience in CDISC and ADaM standardsDemonstrated success in the assurance of deliverable quality and process compliance.Strategic thinking - ability ... to turn strategy into tactical activities; design of statistical databases with the end in mind that optimize analysis and reporting and leverage departmental standards and industry best-practices.Ability to anticipate stakeholder requirements.** Preferred… more
- Merck & Co. (North Wales, PA)
- …stakeholder requirementsPreferred Skills and Experience: Demonstrated success in the assurance of deliverable quality and process compliance. Strong working ... knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)US and/or worldwide drug or vaccine regulatory application submission experience including the development of electronic submission deliverablesExperience assuring programming… more
- Cipla (Hauppauge, NY)
- …External Business stakeholders - Manufacturing, Packaging, Quality Control, Quality Assurance , R&D, Engineering, Finance, HR etc., IT business partners Corporate ... IT Infrastructure and security team Master Control - MES partner Kevin - SCADA implementation partner PLC Vendors for validation activities Manufacturing and Packaging Machine Vendors QC Instruments vendor - Labware, Empower etc QA, R&D and RA Application… more
- HP Inc. (Austin, TX)
- …will specialize in Cybersecurity regulatory compliance, PCI-DSS compliance, third-party assurance , client audits, and mature compliance standards and policies. ... leadership role will be responsible for proactive regulatory adherence, external assurance engagement, internal compliance governance. You will serve as a critical… more
- Insmed Incorporated (NJ)
- …closely with Medical Affairs and other support functions (eg Quality Assurance , Compliance, Legal, etc )Who You Are:Bachelor's degree in information technology, ... Computer Science, or related technical fieldMinimum 7+ years of experience in IT with focus on healthcare/pharmaceutical industryExperience with medical affairs processes and regulatory environmentsStrong technical knowledge of medical affairs applications and… more
- Insmed Incorporated (NJ)
- …with business objectivesCollaborate closely with cross-functional teams including Quality Assurance , IT, CSV, and Compliance departmentsEnsure that Disaster Recovery ... meets the requirements of the businessWho You Are:Bachelor's degree in Computer Science, Information Technology, or related field7+ years of experience in IT with specific focus on Compliance-related systemsTechnical knowledge of LMS applications, compliance… more
- Formation Bio (New York, NY)
- …with other CMC groups (analytical development, supply chain, etc) quality assurance , regulatory, clinical pharmacology and project management to support short and ... long term program objectives. CRO and CDMO Management: Oversee and manage drug product vendors, for both development and manufacturing, ensuring high-quality deliverables and compliance with GMP and regulatory standards. Documentation: Author and review… more
- Terumo Medical Corporation (Elkton, MD)
- …Elkton, MD, US Company: Terumo Medical Corporation Department: TIS Design Assurance /Quality Engineering **Job Summary** The Design Quality Engineer (DQE) II will ... plan, coordinate, and manage the quality assurance (QA) activities associated with one or multiple New...of new products. This individual will provide overall Quality Assurance (QA) leadership and partner with the NPD organization… more
