- Repligen (Hopkinton, IA)
- …role is responsible for inspecting, auditing and reporting on in-process and final inspection of single use assembly parts at the Hopkinton, MA production facility, ... customer quality standards.ResponsibilitiesThe QC Inspector I will be responsible for:Conduct inspection of single use assembly designs of customers and approves or… more
- Merck & Co. (Durham, NC)
- …Operations areas (sterile supply, weigh/dispense, media, stabilizer/prep, thaw/pool, filling, capping/ inspection , clean utilities etc.) located in aseptic and clean ... related equipment (eg Autoclaves, Fillers, Lyophilizers, Cappers and Automated Inspection MachinesThe ability to satisfactorily perform all types of industrial… more
- Merck & Co. (Durham, NC)
- …Operations areas (sterile supply, weigh/dispense, media, stabilizer/prep, thaw/pool, filling, capping/ inspection , clean utilities etc.) located in aseptic and clean ... related equipment (eg Autoclaves, Fillers, Lyophilizers, Cappers and Automated Inspection MachinesThe ability to satisfactorily perform all types of industrial… more
- Aequor (Davie, FL)
- …- 6 months with the possibility of extension. Core essential skill sets :1. Electrical field degree with a minimum of 2 years working with electrical systems (24v - ... as computer work, preparing and analyzing data, extensive reading, and visual inspection involving small defects, small parts and/or operation of machines (including… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …change request; manage interactions with Vendor, finalize, and execute amendment.Audit Ready/ Inspection Prep: As per the audit requirement and processes, storage of ... critical procurement documents is required to be Audit/ Inspection ready at all times; these documents must be clearly filed and retrievable. Perform quality audits… more
- Merck & Co. (Rahway, NJ)
- …submission data standards including SDTM, ADaM, clinical site data for CDER inspection planning, etc.The incumbent will be responsible for continuous improvement of ... in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5 years SAS programming experience in a clinical trial… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …The individual in this role will also be responsible for overseeing inspection readiness and supporting internal audits and Health Authority (HA) inspections. For ... GRA processes and ways of workingDrive activities required for GRA to be inspection ready, and support addressing any observations or findings that may result from… more
- Repligen (Waltham, MA)
- …NCMRs: Identify and document nonconforming material detected during incoming inspection , production, or customer complaints. Ensure accurate logging of issue ... assurance.Qualifications Bachelor's degree in engineering, Quality, or related technical field . 5+ years of experience in supplier quality engineering, manufacturing… more
- Merck & Co. (Durham, NC)
- …of both drug substance and drug product, including product inspection , warehouse, utilities, and quality control laboratories.The Specialist, Operations will ... Experience and Skills:Bachelor's degree in an Engineering or Science related field with minimum of 2 years post-degree experience in-manufacturing, operations,… more
- Merck & Co. (Rahway, NJ)
- …and external quality audits and maintain laboratory state of permanent inspection readiness Author or contribute to Standard Operating Procedures (SOP) ... each level) -Bachelor's degree, or higher, in analytical chemistry or related field with 3+ years post-degree relevant industry experience. Required Experience and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …investigations, support and manage change controls, and maintain permanent inspection readiness and actively support regulatory inspections.Lead facility operating ... the organization.RequirementsBachelor's degree in Engineering, Life Sciences, or related field (required).Advanced degree (MS, MBA, or PhD) preferred.Minimally 12+… more
- Merck & Co. (Rahway, NJ)
- …assembly equipment integrated processes such as ultrasonic welding and vision inspection systems.Author technical content of assembly process FMEAs to capture ... not apply to, and daily in-person attendance is required for, field -based positions; facility-based, manufacturing-based, or research-based positions where the work… more
- BioAgilytix (Durham, NC)
- …documentation is always ready for FDA, EMA, or sponsor inspection .Minimum Preferred QualificationsBachelor's degree in data science, Information Management, Computer ... Science, or related field ; master's degree preferred.10+ years in data management, governance,...preferred.10+ years in data management, governance, or a related field , ideally in a highly regulated industry (life sciences,… more
- City of Spring Hill Kansas (Spring Hill, KS)
- …public administration, engineering, architecture, landscape architecture, geography, or related field required. A combination of education and experience may be ... planning and development function as well as codes and building inspection . This employee should possess excellent communication, organizational, and public relation… more
- Insmed Incorporated (San Diego, CA)
- …interpretation of results and reporting that stands up to regulatory inspection .Demonstrated expert knowledge of scale-up principles with respect to viral vector ... years experience in life sciences, chemical engineering, biochemistry, or related field .Experience working in a biopharmaceutical laboratory focusing on viral vector… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …input on and authors SOPS, SOIs, and process guides. Participates in inspection preparation activities and internal and external audits and audits CAPA ... in nursing, pharmacy, life sciences, health care or related field ; requiredPharmD preferredMaster's Degree Life Sciences preferred Experience Qualifications… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as required to assure compliance with PV agreements.Participate in audit and inspection readiness activities. Provide input for re mediating PV system deficiencies ... Degree Nursing, Pharmacy, Life Sciences, Health Care or related field requiredMaster's Degree Life Sciences preferredPharmD Life Sciences preferred… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …mindset, a Right First Time culture of quality, permanent inspection readiness compliance mindset and passionately drives continuous improvementProvides technical ... Facilities and Engineering, Validation.Requirements B.Sc./M.Sc. in Biological/Biochemical Science/Bioengineering related field . Trade / Technical School Certification or Certification in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Good Practices Guides, and RBA/CSA methodologies to ensure compliance and inspection readiness.Stay current with emerging technologies and industry trends; lead ... in Computer Science, Life Science, Engineering, Information Technology, or related field - Required Master's Degree in Computer Science, Life Science, Engineering,… more
- Novo Nordisk Inc. (Durham, NC)
- …work environments depending on site. May position oneself within confined spaces for inspection if required of the role. Ability to work in loud noise environments ... vehicle based on the role. Qualifications Bachelor's Degree in engineering/related field or an equivalent combination of experience & education required. Minimum… more
