- Aequor (Thousand Oaks, CA)
- …compliance with approved processes and training requirements Audit & external inspection support Job Summary Responsible for: Line Management of Case Management ... regulations as it relates to case intake and processing Providing audit/ inspection support for case management related activities Undertake activities delegated by… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …audit actions related to the siteEnsures and maintains a state of inspection readiness.Perform compliance walkthroughs as part of audit/ inspection readiness ... activities to ensure that the site is an inspection ready state.Perform tasks in a manner consistent with the safety policies, quality systems and cGMP… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …the finishing team to perform responsibilities associated with inspection , packaging, labeling, packing, palletizing, cleaning, reconciliation, traceability, ... lenses permitted) as demonstrated by a current eye exam for inspection activitiesEducation and Experience Requirements: High School Diploma or equivalent required;… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …coordinate SOP Training and effectiveness beyond Read and Apply training in LMS. Inspection Readiness Provide support for audits, inspections and inspection ... requirements related to global health authority inspections, participation in inspection activities and finding remediation preferredDemonstrate ability to combine… more
- Aequor (Thousand Oaks, CA)
- …as well as understand, follow and document batch records for the inspection and packaging process. Reconcile components and products, and calculate product exposure ... Skills: ; filling and finishing manufacturing experience, preferably vial inspection ; understanding of measurements, calculations and the metric system ;… more
- Aequor (Bothell, WA)
- …hands-on operations in the areas of shipping of GMP material, receiving, inspection , storage, transferring and issuing inventory of materials, drug substance in ... intermediates and QC samples with IATA/DOT 19 CFR Certification. Receipt, inspection and quarantining of GMP raw materials and manufacturing aides. Material… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …team in Lenoir, NC. The QC IRMI Technician is responsible for performing QA inspection , sampling, AQL, and release labeling of raw materials to be used in ... production. Job Responsibilities Perform QA inspection of incoming raw materials prior to their use in productionPerform AQL sampling and sampling breakdown of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and due diligence activities for assigned product(s), as neededActs as audit/ inspection Subject Matter Expert (SME) for safety surveillance and risk management ... for assigned product(s), through inspection readiness preparation, and may serve as the primary or back-up SME, and may collaborate with team on CAPAs, including… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …waste, and industrial hygieneRepresent EHS in site Tier meetingsManage EHS inspection program. Drive implementing inspection action plans and closureDevelop ... and review site SOPs and plansDevelop and provide EHS training content through instructor-led training (ILT) and computer-based trainings (CBT). Ability to effectively deliver training to diverse audiences.Perform incident investigations and identify… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Canada Reporting Regulations & Audits: Drive preparedness for regulatory authority inspection and internal audits for PV operational activities for NAO; participate ... as Subject Matter Expert (SME) and mentor colleagues/direct reports in audit/ inspection preparedness and participation Serves as NAO's Lead regarding FDA and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Materials Planning, Work Centers, Bill of Materials / Recipes, Costing and Quality Inspection attributes. This role will partner with the IT team and collaborate in ... BOM, Recipes, MRP, MPS, Work Centers, Batch Management, Quality Inspection , Costing among others.Collaborate with business stakeholders, collaboration partners, and… more
- Merck & Co. (Durham, NC)
- …substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection , utilities, and warehouse.Our ability to excel depends on the ... integrity, knowledge, imagination, skill, diversity, and teamwork of people like you.- To this end, we strive to create an environment of mutual respect, encouragement, and teamwork.- As part of our global team, you'll have the opportunity to collaborate with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technical, regulatory, and operational risks while ensuring these systems are inspection and audit ready. Overall accountability, ensuring higher quality project ... outcomes with optimal use of resources.- Provide such reports that are required to update both management and the business on the progress and status of informatics projects. Contribute to the IT portfolio management process and participate in IT and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …basis.Prevent product/label mix-upsSupervise activities that support the inspection , packaging, labeling, packing, palletizing, cleaning, reconciliation, ... traceability, training, and/or accurate as well as timely completion of finishing batch records and production paperworkConduct employee reviews and provide coaching as appropriate; maintain performance and attendance recordsConduct shift hand-off meetings, to… more
- Eisai, Inc (Raleigh, NC)
- …automated parenteral manufacturing processes, including isolators, automated inspection , Manufacturing Execution Systems and electronic batch release.Competent ... in analyzing complex products, production, and testing issues.Demonstrated scientific problem-solving capabilities.Direct experience managing external partners such as CMOs and labs.Experience in batch disposition, deviation management, change control, and… more
- Novo Nordisk Inc. (WA)
- …Participates in the preparation, conduct and follow-up of audit and inspection activities, collaborating with relevant internal and external stakeholders to develop ... and implement Corrective and Preventive Action Plans (CAPA) Shares information, collaborates and provides relevant input and guidance to other areas within NACD, CMR, and Global partners Demonstrates technical proficiency within responsible areas, staying… more
- Merck & Co. (Durham, NC)
- …processing of both drug substance and drug product, including product inspection , and quality control laboratories.The Specialist, Technical Operations will be ... responsible for providing technical support as part of one of the drug substance or drug product Technical Operations teams.Position Responsibilities:Reporting to the Technical Operations Associate Director the incumbent will independently manage project… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to assure compliance with PV agreements. Participate in audit and inspection readiness activities. Provide input for remediating PV system deficiencies cited ... in audit/inspections. Implement effective corrective and preventative actionPV Regulatory Intelligence: Oversees the management of PV Regulatory Intelligence including gathering, monitoring, analyzing and disseminating information across CSPV stakeholders for… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …perform close activities such as: reading, writing, and analyzing; and visual inspection . The working environment includes a variety of physical conditions including ... noise, inside and outside conditions, working in narrow aisles, and temperature changes; atmospheric conditions including: odors, fumes, and dust. Local and International Travel: 0-10%. We commit to an inclusive recruitment process and equality of opportunity… more
- Aequor (Devers, TX)
- …Recovery/Service Continuity, etc. Provide IT leadership to site regulatory inspection readiness and data integrity initiatives. Participate in high-level strategic ... communications with the business and site leadership teams. Ensure the reliability, security, and scalability of the organization's IT infrastructure, including networks, servers, and storage systems. Oversee the implementation and maintenance of disaster… more
