- Merck & Co. (Rahway, NJ)
- …working knowledge of standards relevant to device components and combination products, including ISO 11608, ISO 11040, ISO 80369, as well as ... performance tests related to container closure integrity and dose accuracy, among others.Proven track record of applying analytical skills in product test method design, development, and validation.Working knowledge of analytical test method technology… more
- 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
- Twist BioScience (South San Francisco, CA)
- …other locations worldwide. This includes maintaining and supporting CGMP and ISO certified production facilities.What You'll be DoingResponsible for the management ... design, and execution, including reconfiguration and expansion.Follow regulatory and ISO 13485 requirements.What You'll Bring to the TeamBachelor's degree or… more
- NVA (Chambersburg, PA)
- …practice. 6 exam rooms, treatment area, large surgery suite, dental suite, and ISO ward. Full In-house laboratory. In house ECGs run and interpreted. Laser surgery. ... Excellent surgical monitoring capabilities. Digital X-ray system with excellent imaging quality in seconds as well as Digital dental x-rays . Ultrasound. Ultrasonic Dental equipment. Complete pharmacy. Newest version of AVImark software. Prompt Care… 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 8 years of experience in… 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)
- …Autoinjectors, ensuring compliance with industry standards and regulatory requirements (eg, ISO 13485, FDA regulations). Actively seek out, anticipate, and solve ... testing.Regulatory Compliance:Strong knowledge of relevant regulatory requirements such as ISO , USP, FDA guidelines, and other global regulatory standards pertaining… more
- Aequor (Irvine, CA)
- …and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies pertaining to medical devices ... Knowledgeable of FDA regulations, 21 CFR part 820 and Part 803 and ISO 13485 standard Strong computer skills (including Excel) Demonstrated written and verbal… more
- Twist BioScience (South San Francisco, CA)
- …various HR Reports eg Recruitment, Retention, candidate pipeline, etc.;Follow regulatory and ISO 13485 requirementsWhat You'll Bring to the Team BA/BS degree or ... HR Reports eg Recruitment, Retention, candidate pipeline, etc.;Follow regulatory and ISO 13485 requirementsWhat You'll Bring to the TeamBA/BS degree or equivalent… more
- Repligen (Clifton Park, NY)
- …molding of silicone rubber Ability to gown appropriately and operate in an ISO 7 environment Execute to Production Schedule and execute assigned tasks Operate ... equipment following SOP's and training guidelines Report any equipment/mold issues to supervisor Responsible for following SOPs and safety procedures Responsible for area cleanliness Read/understand molding drawings Basic math competency Understanding of… more
- Novo Nordisk Inc. (Boston, MA)
- …(11) years of experience in quality (quality assurance, quality control, and ISO standards required, preferably in a cGMP manufacturing environment Knowledge and ... full understanding of c GMP and all relevant laws and guidelines required Documented knowledge and experience with quality assurance, quality systems, quality audits and quality management including cGxP and ISO9000 standards eg, ISO13485 required Experience… more
- Aequor (Golden Valley, MN)
- …Meet department Quality expectations including: Complying with Medallion and ISO 17025 quality requirements Identifying and addressing quality control issues ... Completing quality investigations in a thorough and timely manner Performing routine instrument maintenance, troubleshooting and other maintenance required by the Reliability Program Maintain a work environment that complies with and Medallion safety rules.… more
- Merck & Co. (Rahway, NJ)
- …(Order to Cash), Planning, Source to Settlement/Tax/Finance, Trade Operations, ISO , Relationship Management, QA, and Compliance. Primary activities include, but ... are not limited to:Lead the development and implementation of GCS processes that align with GCS short- and long-term objectives.Act as the overall knowledge expert of SAP and Global Business Processes for the assigned focus area.Drive business challenges to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of measure, using whole numbers, common factions, and decimals.Aseptic processing in ISO 5 clean room and biosafety cabinets.Knowledge of cGMP regulations and FDA/EU ... guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices.Great attention to detail and ability to follow the procedures.The candidate must be highly organized and capable of working in a team environment with a… more
- Vantive (Plymouth, MN)
- …in FDA regulated environment.Working knowledge of Metrology-related standards ( ISO /IEC 17025, ANSI/NCSL Z540.3, etc.) and industry standards (CFR, ... ISO 13485).Ability to work effectively with diverse cross-functional teams.Ability to manage the calibration program independently.Excellent written and verbal… more
- Repligen (Clifton Park, NY)
- …RPS Lean objectives.Ensure compliance with Repligen Policies, SOPs, ISO , and other applicable biopharmaceutical regulations.Oversee scheduling, resource allocation, ... and coordination of multiple production processes and shifts.Monitor production metrics (OEE, yield, throughput, deviations, schedule adherence) and take corrective/preventive action as required utilizing RPS Lean Tools.Supervise, train, and develop production… 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 trackRequired for all levels:Excellent written and verbal skillsDetail orientedGood computer skills and comfort in using computers for all aspects of MFG, experience with Excel and Word,… more
- Repligen (Clifton Park, NY)
- …at $18.50/Hr.)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
- Twist BioScience (South San Francisco, CA)
- …competitive landscapeMeet budget standards by forecasting and managing expensesFollow regulatory and ISO 13485 requirementsWhat You'll Bring to the Team At least 10 ... years of experience concepting, creative directing, designing and developing marketing communicationsDemonstrated a service-driven approach while leading creative initiatives in partnership with other departmentsHave an understanding of life sciences and the… more
- Merck & Co. (Rahway, NJ)
- …products and packaging.Strong understanding of risk management principles, including ISO 14971 and other relevant standards.Strong strategic and analytical thinking, ... with a focus on driving continuous improvement and implementing best practices in technical support and product stewardship.Excellent communication and interpersonal skills, with the ability to effectively engage with internal and external stakeholders.Current… more
