- 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 ... statistical sampling, and control strategyExperience with regulatory fillingsWorking knowledge of ISO 11608 and ISO 11040PSCSCurrent Employees apply HERE Current… more
- Twist BioScience (South San Francisco, CA)
- …The individual is responsible for ensuring compliance to 21 CFR 820, ISO 13485, EU IVDR and other applicable international / local regulatory requirements.What ... systems.Additional responsibilities as assigned.Ability to travel 10%Follow regulatory and ISO 13485 requirementsWhat You'll Bring to the TeamBachelor's degree in… 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 ... manufacturing is a plus.Prior experience in glass container handling/assembly and complex medical device manufacturing (molding and assembly) is preferred but not required.Preferred:Experience in machining, prototyping and 3D printingRudimentary understanding… more
- Merck & Co. (North Wales, PA)
- …NDA/MAA, agency background packages, post-approval submissions/variations, 510(K)s, CE marking, ISO and responses to health authority questions per established ... manufacturing Understanding of - IDE/IND/510(k) clearances/CE mark authorizations and ISO standards Experience in NDA/BLA/post-approval space in medical devices or… more
- Repligen (Waltham, MA)
- …customer regulatory enquiresSupport product change control assessmentsSupport facility ISO certification audits, as requiredEffectively problem solve and develop ... continuous monitoring of International regulatory standards (eg WHO, EMA, FDA, ISO )Develops & maintains Global Regulatory SOPs that define the cross functional… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …prepare for FDA and other agency auditsEnsure site/system validation program meets FDA, ISO and EU requirementsCollaborate with peers and stakeholders to in QA and ... related science fieldDemonstrated knowledge and application of FDA cGMP/GCP regulations, ANSI/ ISO /IEC/ASQC standards, and 21 CFR Part 11 in a manufacturing… 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
- Merck & Co. (Rahway, NJ)
- …control measures, and performing overall device risk evaluations in compliance with ISO 14971 and other relevant standards. Ensure alignment with corporate policies ... and communicate effectively with cross-functional stakeholders and external suppliers.Support Design Transfer activities to internal and external sites ensuring proper translation and implementation of risk control measures.Analyze information from post-market… more
- Repligen (Clifton Park, NY)
- …M-F 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
- Merck & Co. (Rahway, NJ)
- …engineering, and/or capital deliveryRequired skills:Knowledge of concepts and application of ISO , cGMP (CFR part 21/Annex 1 and 2), GDP, and data ... integrity expectations from regulatory agencies with large molecule drug substance development and productionKnowledge of our company's Capital Management Process, Capital Team Leadership experience, continuous improvement, Lean, and Change Management skills,… 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. (Durham, NC)
- …regulatory requirements computer system, such as 21 CFR Part 11, GAMP5, ISO , Data Integrity preferred Experience with Risk Assessment & Vendor Assessments required ... Minimum of four (4) years of experience in reviewing GMP documents for compliance purposes for approval of quality documentation required Excellent troubleshooting skills with ability to identify root cause of problem required Demonstrated knowledge of… more
- Novo Nordisk Inc. (Durham, NC)
- …Ensure site compliance with Regulations, International Organization for Standardization ( ISO ) standards, corporate & local SOPs Review & approve documentation ... for Quality approval - components/raw material, batch records, change control requests, deviations & validation documents Perform QA presence & process confirmation on shop floor Participate in project teams as a quality resource Support, review & approve… more
- Twist BioScience (South San Francisco, CA)
- …internal and external policies, regulations and lawsFollow regulatory and ISO 13485.What You'll Bring to the Team [Competency/Qualifications]B.A at Business, ... Industrial Eng, Life Science or related field or equivalent experience.7+ Years' experience as a Global Sourcing leader or in a similar position.Deep knowhow commodity strategies development.Experience with RFQ implementation and executionSuperb communication… more
- Novo Nordisk Inc. (Boulder, CO)
- …new IT applications Demonstrated knowledge of US FDA, ICH Q7, & ISO regulations, guidelines, and applications of cGMP's within Quality Control laboratory ... Demonstrated knowledge of pharmaceutical industry validation requirements as it relates to GMP Quality Control laboratory Excellent written & oral communication skills & the ability to author scientific & technical reports preferred Proven expertise in leading… more
- Merck & Co. (Rahway, NJ)
- …knowledge of data standards for pharmaceutical products, such as IDMP ISO standards for identifying medicinal products and WHO Drug DictionaryMaintain pharmaceutical ... product reference data (non-company)Qualifications:Education:Degree in chemistry, chemical engineering, or related scientific discipline plus relevant pharmaceutical/biotech industry experience - Bachelor's and 8+ years, Master's and 6+ years, PhD and 3+… more
- Merck & Co. (Rahway, NJ)
- …supporting mechanistic modeling and digital twin applications in cGMP settings (eg, ISO , CFR, ICH, and USP).Applied understanding of QbD principles, design of ... experiments (DOE), and model validation frameworks for process modeling.Working knowledge of statistical process control (SPC), multivariate analysis (MVA), and/or process analytical technologies (PAT) techniques for biologics processes with experience in… more
- Repligen (Clifton Park, NY)
- …as necessary.Ability to gown appropriately and operate in an ISO 7 environment (cleanroom)Operate equipment following procedures and training guidelines.Responsible ... for following safety procedures.Read/understand molding drawings.Basic math competency.Understanding of measuring instruments.Inspection and cleaning of partsQualificationsOccasionally lift 50 lbs. Must understand (written and verbal) English and have 20/20 or… more
- Repligen (Clifton Park, NY)
- …raw materialsAbility to gown appropriately and operate in an ISO 7 environmentOperation of extruders and associated production equipmentIn-process dimensional ... measurements using precision instrumentsResponsible for following SOPs and safety proceduresResponsible for area cleanliness and inspection readinessAbility to lift 50lbs, must speak English and have 20/20 or corrected 20/20 visionTypical hours of operation… more
- Repligen (Waltham, MA)
- …ICH guidelines for analytical assays.Experience working within a cGMP/ GLP, and ISO regulated quality system.Ability to work independently and multi-task in a ... collaborative environment.What Repligen OffersRepligen offers you a competitive remuneration package, including a yearly bonus, non-contributory pension, generous PTO, partial compensation on your personal health insurance and flexible working hours. But most… more
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