- Repligen (Waltham, MA)
- …Leader, Chromatography & Proteins.ResponsibilitiesThe Director, Quality will be responsible for:Maintaining site compliance to ISO 9001 for all aspects of the ... hosting customer/regulatory audits and Certificate of Quality generation at an ISO 9001:2015 certified manufacturing site. We are an innovative life sciences… more
- Merck & Co. (Rahway, NJ)
- …Development and with external suppliers.Understand and apply regulatory / compliance requirements relative to design controls and risk management activities.Lead ... 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… more
- Merck & Co. (Rahway, NJ)
- …knowledge of regulatory requirements and standards (21 CFR Part 4, 21 CFR Part 820, ISO 13485, ISO 14971 etc.) -and industry standards related to medical device ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more
- Repligen (Hopkinton, IA)
- …QA/QC Director.This position is responsible to actively participate in the Repligen ISO 9001 Quality Management System. This role is responsible for assisting the ... department.Organize and update training files as necessary to maintain compliance .Copy, scan, and file records appropriately.Process requests and generates labels… more
- Repligen (Rancho Dominguez, CA)
- …systems, process engineering, and equipment qualification, preferably within GMP or ISO 9001 environments. Success in this role requires technical proficiency, a ... and site expansion. Identify and implement process improvements, ensuring compliance with industry standards and regulations. Develop and maintain engineering… more
- Repligen (Clifton Park, NY)
- …the site expansion programs, implementing quality management systems and maintaining ISO certification. The individual will play a leadership role in scaling ... abilities. Experience working in a classified cleanroom, and knowledge of GMP/ ISO /document-controlled processes would be beneficial. Attention to detail, and the… more
- Merck & Co. (Durham, NC)
- …establishing a strong business partnership and ensuring excellence in Compliance , Supply, Continuous Improvement, and Cost Management.--The Associate Director, ... Lead Periodic Business and Operations Review Meetings (with External Partner).-- Compliance :-Achieve compliance goals through a risk-based approach (Safety… more
- Twist BioScience (South San Francisco, CA)
- …and SOP's. This role is crucial in supporting global product compliance , ensuring that all documentation accurately reflects regulatory requirements and product ... maintain Safety Data Sheets (SDS) for all Twist products, ensuring compliance with global regulations. Collaborate with cross-functional teams to obtain necessary… more
- Repligen (Waltham, MA)
- …growing Supplier Quality team. You will a key role in ensuring the quality, compliance , and performance of Repligen's global supplier base. This is an opportunity to ... Notifications (SCNs)Evaluate and manage Supplier Change Notifications to ensure compliance with internal and regulatory quality standards.Coordinate cross-functional teams… more
- Merck & Co. (Rahway, NJ)
- …combination products cGMP, Quality System Regulation, FDA Human Factors guidance, ISO 14971, 11608 and 11040, EN 62366, Council Directive 93/42/EEC, ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more
- Repligen (Hopkinton, IA)
- …productsPackage and label finished productsWork with a Team in a fast-paced ISO certified cleanroom environment for 8 hours a dayPerform daily housekeeping tasks ... experienceHS Diploma or equivalentDue to the nature of the work and compliance with safety protocols/regulations, fluency in English (reading and writing) is… more
- Twist BioScience (South San Francisco, CA)
- …that all products processed, packaged, stored, and distributed are manufactured in compliance with all Regulatory, Customer, and Twist requirements. In this position ... and summarizing information and trendsWrite/review product quality documentationFollow regulatory and ISO 13485 requirementsWhat You'll Bring to the Team BS/MS in… more
- Twist BioScience (South San Francisco, CA)
- …execution of signed partnerships, maximizing their impact on business goals. Compliance & Quality:Ensure all activities comply with applicable regulatory standards ... including ISO 13485 and other relevant quality requirements.Qualifications & Experience:8+ years of relevant experience in the life sciences industry, with at least… more
- Geronimo Energy LLC (Bloomington, MN)
- …. 5+ years of experience, with at least 3 years focused on NERC and RTO/ ISO compliance responsibilities. . Deep understanding of NERC, and ISO /RTO regulatory ... Position Summary: Geronimo Power, LLC is seeking a NERC & RTO/ ISO Regulatory Compliance Manager to provide strategic guidance on regulatory matters affecting the… more
- Amentum (Bismarck, ND)
- **Amentum seeks an ISO 27001 Compliance Engineer** Amentum is a global leader in advanced engineering and innovative technology solutions, trusted by the United ... employees in approximately 80 countries across all 7 continents. The ** ISO 27001 Compliance Engineer** is a remote-telework position that supports our ISO… more
- Alight (IN)
- …in Alight technology, security, and business operations to aid in audits and verifying ISO compliance + Work with business leaders and other stakeholders to ... Compliance team, this position will provide help manage ISO audits and the applicable controls. With a deep...in business operations and delivery. + Interpret patterns of ISO non- compliance to determine impact on levels… more
- The Coca-Cola Company (Columbus, OH)
- …Management Systems (QMS); Regulatory Compliance ; Compliance ; Team Collaboration; ISO Training; GMP Auditing; ISO Compliance Pay Range:$85,000 - ... organization. Your primary focus will be on ensuring adherence with ISO standards, regulatory compliance , company requirements, facilitating continuous… more
- Robert Half Finance & Accounting (Columbia, MD)
- …a team dedicated to providing top-tier advisory and attestation services for ISO 27001 compliance , helping clients streamline their processes, strengthen their ... or information systems. + Experience: + Minimum of 8 years in ISO 27001 compliance or related areas. + Previous experience working with commercial clients. +… more
- TestPros (Sterling, VA)
- …Responsibilities: + Lead the design, implementation, and maintenance of the ISMS in compliance with ISO 27001 standards. + Conduct risk assessments and develop ... security risks. + Coordinate and conduct internal audits to ensure ongoing compliance with ISO 27001 and prepare the organization for external audits. + Develop… more
- Nammo Defense Systems, Inc (Scranton, PA)
- …Adept at developing, implementing, and managing robust quality assurance programs in compliance with ISO 9001, and MIL-STD requirements. Proven success leading ... is looking for an experienced and results-driven Quality Control Manager / ISO Management Representative with 5+ years of leadership experience in Quality control.… more
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