- Merck & Co. (Rahway, NJ)
- …Product current Good Manufacturing ruling (21CFR part 4), Device Risk Management ( ISO 14971) and other worldwide regulations and requirements. This position provides ... of applicable medical device regulations (21CFR820, 21CFR Part 4, EU MDR, ISO 13485).Experience with Design Controls / Corrective Action and Preventive Action /… 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
- 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
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …environmentAbility to lift 50 lbs. unassisted with proper PPEFamiliarity with GMP/GLP, ISO 9001:2008 and ISO 17025:2017 Attains & maintains aseptic gowning ... certificationAbility to work hours necessary to support shift productions, may include participation in a 24/7 team call out rosterStrong verbal and written communication skills, along with math, and measuring skills Demonstrates good organizational skills,… more
- Twist BioScience (South San Francisco, CA)
- …to monitor effectiveness of production order output.Follow regulatory and ISO 13485 requirements.Assist in lab cycle counts and reconciliations.Analyze material ... or 4 year work experience equivalent required.Physical Activities Working in an ISO 13485 environmentThe base cash compensation for this California-based role is… more
- Merck & Co. (Rahway, NJ)
- …FDA combination products cGMP, Quality System Regulation, FDA Human Factors guidance, ISO 14971, 11608 and 11040, EN 62366, Council Directive 93/42/EEC, etc.Proven ... track record of applying analytical skills in product design, development, and validationSelf-motivated with ability to work independentlyProven ability to lead team members of diverse skill sets and backgroundsStrong interpersonal skills and a strategic… more
- Novo Nordisk Inc. (Durham, NC)
- …Reports to Manager, QA. Essential Functions Ensures site compliance with Regulations, ISO standards, corporate & local SOPs Reviews & approves documentation for ... Quality approval - batch records & other documentation Supports & reviews investigations & root-cause analysis Participates in process confirmations & Go Look Sees Follow all safety & environmental requirements in the performance of duties Other… more
- Twist BioScience (South San Francisco, CA)
- …a timeExperience with agile software deployments in a controlled environment ( ISO , CLIA, eg) including integration testing, system validation, integration testing, ... and testing documentationStrong communication and documentation skills including the ability to tailor the same content to multiple audiences.Experience with deployments from start to finish and beyond; proven track record of successful software releases… 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
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …current industry practices and guidelines including those required / outlined by the FDA, ISO , EU and ICH. Understand 21 CFR Part 11, cGAMP, and other regulatory ... guidance associated with computer / automation based systemsAbility to read electrical schematicsLow-voltage electrical design and layout.Strong technical writing and communication skillsStrong electrical and mechanical troubleshooting skillsKnowledge of… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …industry practices and guidelines including those required / outlined by the FDA, ISO , EU and ICH.Understand 21 CFR Part 11, cGAMP, and other regulatory guidance ... associated with computer / automation-based systemsAuto CAD and networking experience a plus, but not a requirementEducation and Experience Requirements: Bachelor's degree in engineering, Computer Science or related discipline, with a minimum of 5 years of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in a Quality Control setting is preferredExperience with aseptic processing in ISO 5 clean room and biosafety cabinets is requiredKnowledge of cGMP regulations ... and FDA/EU guidance related to manufacturing of cell-based products is requiredKnowledge of Good Tissue Practices is required.Detailed knowledge of CAR-T QC test methods and related equipment is preferredExcellent written and oral communication skill are… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …standards and resultsAssist in the implementation and maintenance of ISO 17025 (if applicable) Quality Management SystemComplete documentation and reports ... of all calibration and maintenance actionExperience Requirements5 years of solid calibration and metrology experienceAble to establish and maintain metrological traceability for laboratory measurement parametersThorough knowledge and application of measurement… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in a Quality Control setting is preferred.Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is required.Knowledge of cGMP regulations ... and FDA/EU guidance related to manufacturing of cell-based products is required.Knowledge of Good Tissue Practices is required.Detailed knowledge of routine and non-routine testing and sampling methods, techniques and related equipment is preferred.Detailed… 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
- Twist BioScience (South San Francisco, CA)
- …duties and projects as assigned by department head Follow regulatory and ISO 13485 requirementsWhat You'll Bring to the Team 4+ years relevant facilities ... / operations experience High School diploma or equivalent Excellent oral and written skills and proficiency with all Microsoft Office applications is required Customer service oriented - pleasant, friendly, cheerful, energetic, courteous and professional… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …needs and is efficient for the employees. Serve as the company Quality Representative for ISO 13485, 21 CFR part 820, 21 CFR part 4, and all associated regulatory ... requirements.Drive risk management in design, validation, and ongoing manufacturing. Ensure strong and efficient process validations to ensure manufacturing success.Drive strong internal audit program and robust management reviews.Drive strong quality… 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
- 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)
- …medical devices and IVD devices.Experience with EU regulations for IVDRExperience with ISO 13485 and GMP requirements.Deep knowledge of Risk management and Design ... ControlExperience with Six Sigma or other quality improvement methodologies.About 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… more
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