- 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
- 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, ... to ensure conformance to the organization and customer quality standards.ResponsibilitiesConduct inspection of single use assembly designs of customers and approves… 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...individuals to close any gaps. To prepare for an Audit/ Inspection , the first step is to create a Vendor… 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
- AUROBINDO (Durham, NC)
- …that the scale is providing accurate information.Check and perform daily inspection of electric forklifts and electric hand trucks.Provide assistance in movement ... and dispensing team.Maintain record keeping of all material movement within the warehouse. Inspection and loading of finished products shipments.To drive the truck to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …functions, internal and external stakeholders to execute audits effectively.Support inspection readiness by preparing clinical teams, Clinical Safety and ... for key Health Authority pre-approval and sponsor-monitor inspections; provide inspection management support and follow-up activities post inspection … more
- Repligen (Clifton Park, NY)
- …for area cleanlinessread and understand quality and inspection documentsread/understand molding drawingsbasic math competencyunderstanding of measuring ... supplies or manufacturing experience is a huge plus.Quality control or inspection experience is highly desirablePrevious experience working in a Cleanroom… more
- Aequor (Cincinnati, OH)
- …scientific glassware in dishwasher according to written procedures Handwashing glassware Inspection of glassware following cleaning to ensure it is safe ready ... Change out pipet soakers on a weekly basis Receive incoming samples Perform inspection of house cleaning checklist weekly Monitor and implement safety procedures as… more
- Insmed Incorporated (San Diego, CA)
- …gene therapy products is preferred.Experience with effectively managing regulatory agency inspection and working with regulators and internal staff to help prepare ... for inspections is required.Experience developing SOPs, reviewing internal clinical, regulatory and medical processes to ensure they are accurately represented in current SOPs is essential.Broad knowledge of risk-based quality systems approaches consistent… 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 ... review meetings and sponsor various department projects to drive continuous improvements and efficiencies within cell therapy Technical Operations.Support organizational design updates, operations organization build, operations ramp-up of commercial and… 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) ... draftingOriginate and own Investigations and Change Management recordsThe successful candidate must function both independently and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment. Strong communications skills and… more
- Repligen (Clifton Park, NY)
- …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 are 2:00pm-10:30pm M-FA minimum of 40hr/week is required, some overtime is necessaryQualificationsHigh School Diploma or Equivalent requiredPrevious experience working in a manufacturing and/or cleanroom… 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 ... patient and process risk and identify appropriate in-process controls to ensure robust and efficient throughput.Develop characterization plans and prototype small-scale equipment to prove out concepts prior to implementation.Conduct testing using tensile… more
- City of Spring Hill Kansas (Spring Hill, KS)
- …planning and development function as well as codes and building inspection . This employee should possess excellent communication, organizational, and public relation ... skills. In addition, exercising independent judgement and simultaneously considering the financial, ethical, legal and regulatory variables that affect the City is vital. Performs complex and professional level management, leadership, budget research, economic… more
- Aequor (Hicksville, OH)
- …lines and roles as necessary to maintain operational efficiency. Performs rework/re- inspection of components/finished goods with minimal conversation and focus on ... product defects. Performs various housekeeping duties such as sweeping/mopping floor, cleaning equipment, fixtures, windows, and walls as needed. Perform minor adjustment on the equipment and documents work performed. Participates in training of new employees.… more
- Merck & Co. (Durham, NC)
- …drug product, including biotech culture growth, harvest, lyophilization, product inspection , utilities, and warehouse.The candidate will support the installation, ... operation, maintenance and/or troubleshooting of biopharmaceutical manufacturing equipment such as washers, autoclaves, tanks, bioreactors, filtration skids, filling lines, lyophilizers and isolators.- Develops Standard Operating Procedures (SOPs) and… 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 ... purification.Work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.Author Standard Operating Procedures, technical reports, process descriptions, including data interpretation and procedures suitable… 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 ... preparation.Case Processing Training: Identifies case processing and related CRO/vendor training needs and reviews case processing project specific training materials. Manages and coaches the PV Vendor Training Coordinator. Qualifications: Successful… 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 ... cited in audit/inspections. Manage the implementation of effective corrective and preventative action PV Agreements and Contracts: Manages PVAs/SDEAs and maintains oversight of PV relevant contracts. Contribute to overseeing and setting standards for PV… 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, or a related field, ideally in a highly regulated industry (life sciences, pharmaceuticals, healthcare).Strong expertise with data integration tools (eg, Microsoft… more
