- Merck & Co. (Rahway, NJ)
- …products. As Director, you will support Quality audits and health authority inspections and ensure any resulting corrective and preventative actions (CAPA) are ... to identify appropriate CAPA to address findings identified during audits and inspections . Monitor CAPA status and ensure CAPA are implemented in accordance with… 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 ... 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …vendor set-up and maintenance, simple negotiations, prepares for audits and inspections , maintains preferred supplier list, maintains and tracks Procurement training ... change request; manage interactions with Vendor, finalize, and execute amendment.Audit Ready/ Inspection Prep: As per the audit requirement and processes, storage of… 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
- Merck & Co. (Durham, NC)
- …meet project, production and supply timelines. Lead aspects of regulatory inspections by presenting and defending technical documentation, investigations, and change ... Degree in Chemical Engineering, Biochemical Engineering, Bioengineering, or related life science field with a minimum of two (2) years of relevant experience or… 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...Degree Nursing, Pharmacy, Life Sciences, Health Care or related field requiredMaster's Degree Life Sciences preferredPharmD Life Sciences preferred… more
- Eisai, Inc (Raleigh, NC)
- …responsible for executing core quality assurance functions, supporting regulatory inspections , and collaborating with internal and external stakeholders to resolve ... on product quality. \tActing as a Subject Matter Expert (SME) during regulatory inspections in assigned area(s) of responsibility.This role requires a high level of… more
- Merck & Co. (Rahway, NJ)
- …sections, and support response to questions and pre-approval inspections from a product development standpointStakeholder Collaboration and Communication:Secure ... aligning with the company's divisional and local site procedures.Support regulatory inspections and maintain proficiency in ISO 13485, ISO 14971-2019, and other… more
- Merck & Co. (Rahway, NJ)
- …degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with eight (8) years of relevant industry experienceOR Master's degree ... in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with six (6) years of of relevant industry experienceORPh.D. in Chemical… more
- Merck & Co. (Durham, NC)
- …according to approved procedures. - Completes in-process testing and inspections supporting the vaccine manufacturing, validation, and development processes as ... 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
- Twist BioScience (South San Francisco, CA)
- …assisting with agenda preparation and minute-taking.Conducting routine EH&S inspections and audits, documenting findings, and identifying potential ... hazards.Supporting the implementation of preventative actions identified through inspections or incident investigations.Assisting in the investigation of EH&S… more
- Merck & Co. (Rahway, NJ)
- …Introductions (NPIs), Process Performance Qualifications (PPQs), Pre-Approval Inspections (PAIs), and best-in-class multi-product launch manufacturing.To achieve ... 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
- Novo Nordisk Inc. (Durham, NC)
- …SAP, PI Historian) Serve as a Lead and SME in supporting audits & inspections for specified AMS solutions Utilize the appropriate cLEAN® tools within the main areas ... role.) Qualifications Bachelor's Degree in Engineering or a relevant field of study from an accredited university required May...an Associate's Degree in Engineering Technology or a relevant field of study from an accredited university with a… 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
- 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
- Merck & Co. (Durham, NC)
- …drug product, including biotech culture growth, harvest, lyophilization, product inspection , utilities, and warehouse.The candidate will support the installation, ... 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
- 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Legend and partner sites.Provide technical support and leadership during Agency Inspections , filing of Submissions, and IRs.Maintain global master batch record and ... required, Ph.D. preferred in technical discipline: engineering, science, or related field .Minimum 8 years of industrial biologics CMC development or manufacturing… 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
