- Eisai, Inc (Nutley, NJ)
- …as well as direct reports.Expert knowledge of industry standard frameworks and best practices - ISO 9001:2015, ISO 27001: 2013, ISO 27002: 2013, ISO ... availability and confidentiality.Experience implementing, managing, and maintaining compliance with ISO 27001: 2013 and other information security industry standards… more
- Merck & Co. (Rahway, NJ)
- …the product design, development, and manufacturing processes.Implement risk management principles ( ISO 14971) in design and development to ensure safe and effective ... integration into product design and development processes (Design Control per ISO 13485, QMSR, Part 4).Lead quality oversight of product validation, verification,… more
- Novo Nordisk Inc. (Durham, NC)
- …Provide backup support for the ISO14001 Environmental Management as well as ISO 45001 Occupational Health & Safety Management Systems Increase the awareness of ... skills in root cause analysis for analyzing accidents preferred Working knowledge of ISO 45001 & 14001 a plus Emergency Management / planning knowledge & experience… more
- Merck & Co. (Rahway, NJ)
- …FDA combination products cGMP, Quality System Regulation, FDA Human Factors guidance, ISO 14971, EN 62366, Council Directive 93/42/EEC, etc.Proven track record of ... sampling, and control strategyExperience with regulatory fillingsWorking knowledge of ISO 11608 and ISO 11040 NOTICE FOR...regulatory fillingsWorking knowledge of ISO 11608 and ISO 11040 NOTICE FOR INTERNAL APPLICANTS In accordance with… more
- Aequor (Irvine, CA)
- …and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies as pertaining to medical ... devices.Minimum Requirements:Bachelor's degree in Engineering1-2 years of relevant experience in a regulated industry (FDA environment preferred)College Graduates Encouraged to Apply!Bachelor's degree in Engineering more
- Aequor (Golden Valley, MN)
- …Methods Perform routine instrument maintenance and troubleshooting Meet Quality control and ISO 17025 requirements Maintain a work environment that complies with and ... Medallion safety rules Cross-functional support across Medallion as business needs dictate Strong organizational and leadership skills, independent decision making, high attention to detail, and service orientation are essential Skillfully handle multiple… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …required Lead, develop, and support measurement methods in compliance with regulations ( ISO 14644, EU Annex 1) Administration of HEPA testing assets Contributes to ... practices (CGMPs) and good documentation practices (GDPs) Understanding of GMP/GLP, ISO 14664, IEST, and EU Annex 1 Standards, Guidelines, and practices.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in a Quality Control setting is preferred.Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is preferred.Knowledge of cGMP regulations ... and FDA/EU guidance related to manufacturing of cell-based products is required.Detailed knowledge of routine and non-routine testing and sampling methods, techniques and related equipment is preferredDetailed knowledge of the shop floor manufacturing process… more
- Merck & Co. (Rahway, NJ)
- …as CISSP, CISM, or GIAC.Frameworks and Standards:Familiarity with NIST, ISO 27001, and other relevant cybersecurity frameworks and standards.Global ... Experience:Experience working with global teams and managing cybersecurity operations across multiple locations, such as US, EMEA, and Asia.Advanced Threat Detection:Experience with advanced threat detection technologies and methodologies.Incident Response… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in order to assure compliance with regulations, standards and guidance such as ISO , CLIA, etc.Ensures that laboratories and / or vendors that are responsible for ... biomarkers, special analytical methods, assays etc., are assessed and that any nonconformance are appropriately mitigated.Ensure approved metrics are in place to monitor and provide proper QA oversight of research area, in close collaboration with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …OSHA DEP, while using guidance documents from NIOSH, ACGIH, NFPA, ANSI, ISO and policies, guidelines, and industry standards as applicableMust be knowledgeable on ... OSHA standard such as Control of Hazardous Energy, Electrical Safety, Confined Space, and Fall ProtectionMaster's degree (MS/MA) in Occupational Safety and Health, Environmental Science, Engineering, or related field is preferredGMP experience is… more
- Genmab (Plainsboro, NJ)
- …knowledge of security and risk management frameworks and standards (eg NIST, ISO ).Excellent knowledge of security standards (eg CIS, NIST) with the ability to ... apply in a concise and pragmatic manner.Deep understanding of Agile and Dev(Sec)Ops development processes and how security controls and processes can be embedded in a flexible but consistent mannerDeep understanding of current and emerging technologies and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …10+ years of experience within Risk ManagementStrong financial background requiredKnowledge of ISO 31000 preferred TravelMust have ability to travel up to 10% ... (global and domestic) Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin,… more
- Eurofins USA Food Testing (North Platte, NE)
- …results. Assist laboratory staff in making sure that analytical work done under ISO meets requirements. Review and evaluate test data generated within assigned area ... of assigned technical staff on test methods, formal SOPs, regulations, ISO requirements, and laboratory policies/procedures applicable to area of responsibility.… more
- Constellis (Herndon, VA)
- …multiple computer systems and platforms, highly preferred Prior experience with ISO standards, to include internal and external audit processes and requirements, ... preferred Strong analytical, problem-solving, and writing skills Ability to prioritize work, and work with minimal supervision or direction Ability to comfortably interact and clearly communicate verbally and in writing with individuals at all levels of the… more
- Constellis (Herndon, VA)
- …cost savings and avoidances Assist with audits, as necessary (DCAA, DCMA, ISO , DOD, Internal, etc.) Other duties as assigned QUALIFICATIONS Bachelor's Degree or ... in a DCMA auditable environment Experience with purchasing in a ISO -9001 environment Experience supporting large programs and Blanket Purchase Agreements (BPAs)… more
- STS Technical Services (Brookfield, WI)
- …Establish, implement, and maintain administrative policies and procedures according to ISO 9001:2015 standards. Work as Designer/Engineer on projects as needed. ... Develop and review 3D CAD models in SolidWorks, Inventor, Creo, and other software. Simplify purchased items to a usable file size. Create mechanical layouts and routed assemblies between main components. Add fabrication details to support drawings. Utilize… more
- Allied Mineral Products (Columbus, OH)
- **Global ISO Coordinator** **Allied Mineral Products** is a leading manufacturer of monolithic refractories worldwide. We are seeking a **Global ISO ... System (QMS) at Allied Mineral Products and all affiliates, ensuring compliance with ISO standards (eg, ISO 9001, ISO 14001, ISO 45001). This role… more
- Komatsu (Longview, TX)
- ISO Compliance Specialist Date: Nov 4, 2024 Location: Longview, TX, US, 75603 Req ID: 30766 Onsite or Remote: Onsite Position Komatsu is an indispensable partner to ... NTC, and Gigaphoton. Job Overview Komatsu Longview Operations is seeking an experienced ISO Compliance Specialist to join our team. The successful candidate will be… more
- KBR (Cherry Point, NC)
- Title: Lead Auditor - ISO Belong, Connect, Grow, with KBR! Program Summary The Marine Corps Prepositioning Program (MCPP) is based in Jacksonville, Florida. We ... equipment for USMC Expeditionary Forces. Job Summary POSITION TITLE: Lead Auditor ISO Ensures compliance with established internal and external control procedures by… more
