- Repligen (Waltham, MA)
- …hosting customer/regulatory audits and Certificate of Quality generation at an ISO 9001:2015 certified manufacturing site. We are an innovative life sciences ... & Proteins.ResponsibilitiesThe Director, Quality will be responsible for:Maintaining site compliance to ISO 9001 for all aspects of the QMS including but not limited… 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 ... Computer Aided Engineering (CAE), Geometric Dimensioning And Tolerancing (GD&T), ISO 13485 Medical Devices, Manufacturing Automation, Mechanical Design, Mechanical… 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 ... related disciplineMinimum 1-2 years' experience in Document Control in an ISO 9001 certified Quality Management System or equivalentStrong knowledge of Microsoft… 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 inspecting, ... (Outlook, Excel, Word)Minimum 0-2 years' experience in Quality Assurance in an ISO 9001 certified Quality Management System or equivalent.Ability to communicate with… more
- Merck & Co. (Rahway, NJ)
- …divisional and local site procedures.Support regulatory inspections and maintain proficiency in ISO 13485, ISO 14971-2019, and other relevant quality management ... systems.Qualifications:Bachelor's degree in Mechanical Engineering, Biomedical Engineer, or a related a technical field (eg, Chemical Engineering, Materials Engineering) required; advanced degree (Master's or PhD) preferred.Minimum of 10 years of experience in… 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, ... etc.-Additionally possess extensive knowledge in traditional worldwide pharmaceutical regulations including but not limited to 21CFR210, 211, 600-680, ICH Q8/9/10, Directive 2001/83/EC and comparable worldwide regulations.Current Employees apply HERE Current… 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 ... Filtration systems (Hollow Fiber, Flat Sheet Membranes) Strong knowledge of ISO 9001 and GMP manufacturing standards. Proficient in SolidWorks/CAD, MS Office,… 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
- Twist BioScience (South San Francisco, CA)
- …(project timeline, meeting minutes) accordingly.Leads projects and team members through ISO 13485 design control process; creates and maintains a high-quality ... teams and driving teams to achieve aggressive goals. Experience with ISO 13485 design control and Quality Management Systems.Superior interpersonal skills and… 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 ... as assignedCut tubing and polymer film to meet tolerances using both manual and automated tools.Safely operate cleanroom machinery by closely following the standard operating proceduresPerform inventory counts and report any inaccuracies on in a timely… more
- Twist BioScience (South San Francisco, CA)
- …and/or organize products for shipping.Work according to Good Manufacturing and ISO practices. Learn, adopt and promote lean manufacturing concepts.Complete all the ... daily assigned tasks to keep the manufacturing schedule on track and report back to Lead and Supervisor.What You'll Bring to the TeamRelevant experience that can indicate success in a high throughput, fast paced laboratory manufacturing environment.Associates… more
- Repligen (Clifton Park, NY)
- …Lead. Responsibilitiesability to gown appropriately and operate in an ISO 7 environmentexecute assigned packaging floor tasks.responsible for following SOPs ... and safety proceduresresponsible for area cleanlinessread and understand quality and inspection documentsread/understand molding drawingsbasic math competencyunderstanding of measuring instrumentsinspection and cleaning of partspart preparation for bagging and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Project management experience a plus Knowledge, Skills, and Abilities Knowledge of Cgmp's, ISO and FDA requirements a plus Able to develop and manage action plans ... to achieve targets Must be detail-oriented with excellent organizational skills as well as excellent oral and written communication skills Must be self-motivated with the ability to work independently with minimal supervision Proven ability to effectively… more
- Twist BioScience (South San Francisco, CA)
- …duties & projects as assigned. Ability to travel 5% Follow regulatory and ISO 13485 requirements.What You'll Bring to the Team Bachelor's degree in a scientific ... discipline (eg, Chemistry, Biology, Biochemistry) or equivalent combination of education and work-related experience. Minimally 2 years of experience Regulatory Operations within a biotechnology, life sciences, or chemical manufacturing company or another… more
- Twist BioScience (South San Francisco, CA)
- …with MRP software, ex. (SAP, NetSuite & Oracle)Ability to work in an ISO , GMP, LEAN Manufacturing environment and follow the lean manufacturing concepts.Training in ... CAPA, HAZMAT, Chemical Hazards, Forklift, and SafetyAbout Twist BioscienceTwist Bioscience synthesizes genes from scratch, known as "writing" DNA. Just as children learn to both read and write, the next phase of development for the genomics revolution is the… more
- Twist BioScience (South San Francisco, CA)
- …the needs of each region - AMER, EMEA and APACFollow regulatory and ISO 13485 requirementsWhat You'll Bring to the Team Bachelor's Degree. MBA or Master's ... DegreeProven track record of managing broad range of marketing channels with demonstrated success in driving revenue growth through e-commerce channels10+ years of experience in marketing in life sciences industry and the strong ability to grasp scientific and… more
- Twist BioScience (South San Francisco, CA)
- …and summarizing information and trendsWrite/review product quality documentationFollow regulatory and ISO 13485 requirementsWhat You'll Bring to the Team BS/MS in ... Biochemistry, Chemistry, Molecular Biology or related field2+ years industrial experience in Operations/QCPreferred QualificationsKnowledge of/experience with Quality Control and Quality Assurance principles, including GMP/ISOKnowledge of molecular biology… more
- Merck & Co. (Durham, NC)
- …and manufacturing for MDCP (21 CFR Part 4, Medical Device Reporting, ISO 13485:2016, EU Medical Device Regulation, etc.). Strategic Sourcing and Contract ... By applying to this Pipeline Advertisement you will be submitting your interest to be contacted for roles similar to what is described in the Pipeline Advertisement.- Position Overview : Our Company is seeking a dynamic and versatile leader for External… more
- Twist BioScience (South San Francisco, CA)
- …troubleshooting and addressing process deviationsPackaging productsAbility to work in an ISO , GMP, LEAN manufacturing environment and follow the lean manufacturing ... conceptsDaily completion of assigned tasks to keep MFG on trackKey Skills/QualificationsMA :0-1 year of relevant lab experience and/or Bachelors or Associates degree in biology, chemistry, biochemistryFamiliarity with or prior experience in a manufacturing… more
- Twist BioScience (South San Francisco, CA)
- …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 5 years in business development, corporate strategy, or related roles.Advanced scientific degree preferred (BS, MS, or PhD in Biology, Genomics, Biotech, or related field); MBA is a… more
