- 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 (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
- 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
- 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 (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
- 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)
- …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
- 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)
- …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
- Leica Biosystems (Miami, FL)
- …Danaher Business System which makes everything possible.The Specialist, Regulatory Compliance for Leica Biosystems is responsible for working with cross-functional ... activities related to Quality Management System (QMS) to ensure ongoing compliance while continuing to develop regulatory affairs skills.This position reports to… more
- Cytiva (Pensacola, FL)
- …therapeutics from discovery to delivery.What you will do:Quality Leadership & Compliance : Serve as the Pensacola site's Quality Management Representative, leading ... QA/QC functions, ensuring regulatory compliance , and aligning with organizational quality goals.Quality Management System (QMS): Implement, maintain, and optimize… more
- Cepheid (Miami, FL)
- … compliance with local, state, and federal regulations and standards including compliance with Food & Drug Administration (FDA), ISO 13485, European Union ... improvements. This position will work with the Senior Manager Quality Systems Compliance .This position is part of the Quality department and will be located… more
- Beckman Coulter Life Sciences (Indianapolis, IN)
- …for Beckman Coulter Life Science.Coaching teams with application of ISO 9001/13485/cGMP/IEC 62304 and quality systems processes throughout product ... particular focus on Design Controls, Document Controls, Risk Management (per ISO 14971), Production, Service Controls. Assuring compliant process and product… more
- Pall (Miami, FL)
- …and/or procedures advises on impact of regulations, devises strategies for compliance , and liaison with regulatory bodies. Investigates and resolves compliance ... and complaints. Audits and evaluates current policies, procedures, and documentation for compliance with regulations and statutes. Determine the need for and prepare… more
- Cepheid (Miami, FL)
- …design control and risk management activities in accordance with FDA and ISO regulations. This position is also responsible to apply scientific knowledge to ... and decisions on product development activities to ensure continued compliance with internal procedures and applicable US FDA, EU...of FDA QSR, EU IVDR and other global regulations ISO 13485 and ISO 14971.Experience in implementing… more
- Pall (Miami, FL)
- …links with customers in line with the Quality Management system including ISO 90001, Advanced Product Quality Planning (APQP), Controls Plans, Failure Mode and ... Effect Analysis (FMEA) processes, and oversee continued compliance and embedding across the business.This position reports to the Plant Director and is part of the… more
