• Aequor (Houston, TX)
    Job title - Receiving Inspection CMM Technician V Location - Houston, TX 77054 - 100% onsite role Duration: 12 months contract Work schedule - Monday through Friday ... Request id# 3446-1 Job Description: We are currently seeking a Receiving Inspection CMM Technician V for the Manufacturing Technical Operations division located in… more
    HireLifeScience (11/06/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …with safety reporting requirements. Key contact person for FDA and Health Canada PV inspections and device inspections as well as key contact for all safety ... Canada Reporting Regulations & Audits: Drive preparedness for regulatory authority inspection and internal audits for PV operational activities for NAO; participate… more
    HireLifeScience (10/05/24)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …to coordinate SOP Training and effectiveness beyond Read and Apply training in LMS. Inspection Readiness Provide support for audits, inspections and inspection ... systems preferredExperience with requirements related to global health authority inspections , participation in inspection activities and finding remediation… more
    HireLifeScience (10/03/24)
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  • 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...requests for finished drug product and API raw materialsPerform inspections and sampling required for retest folders Apply release… more
    HireLifeScience (11/02/24)
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  • Merck & Co. (Rahway, NJ)
    …may include review of documentation and deviation investigations, ensure permanent inspections readiness, regulatory inspection support and monitoring, change ... of contractual and financial awareness.Previous experience participating in regulatory inspections .Be conversant with all domestic and foreign regulations and… more
    HireLifeScience (11/08/24)
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  • Legend Biotech USA, Inc. (Raritan, NJ)
    …manufacturing investigations, support and manage change controls, and maintain permanent inspection readiness and actively support regulatory inspections . This ... individual will need to build strong partnerships with Manufacturing, Engineering, and Quality to ensure seamless execution of daily production schedules. This individual will also lead facility operating review meetings and own various department projects to… more
    HireLifeScience (11/02/24)
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  • Merck & Co. (Rahway, NJ)
    …biologics, vaccines, and devicessupport remediation activities and pre-approval inspection readiness activitiesprovide expert guidance and assistance to our ... and exposure (not less than 5 years) in managing health authority inspections and communications in a pharmaceutical, biotechnology, or device manufacturing site-… more
    HireLifeScience (11/01/24)
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  • Novo Nordisk Inc. (West Lebanon, IN)
    …towards long-term goals Provides input and direct support during regulatory inspections . Supports health authority and corporate audits Implement department action ... close activities such as: reading, writing, and analyzing; and visual inspection . The working environment includes a variety of physical conditions including:… more
    HireLifeScience (10/29/24)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …are in compliant and prepared for regulatory submissions and / or inspections Ensures that appropriate systems, processes are in place to enhance GLP/GCLP ... with key partners and collaborators.Review, define, develop SOPs, instructions, manuals, inspection readiness strategy for GLP/ research unit for global activities… more
    HireLifeScience (10/23/24)
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  • Aequor (Louisville, KY)
    …including leading Event Review Team meetings if applicable. Support audits and inspections . Ensure up to date smartsheets for minor, major, CTETS and missing ... (eg Trackwise, EDMQ, etc) Preferred Requirements Experience in audit / inspection support Technical writing skills Competencies Effective communication skills at… more
    HireLifeScience (10/19/24)
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  • Legend Biotech USA, Inc. (Raritan, NJ)
    …CAPAs, change controls and complaintsReview and approve manufacturing proceduresSupport regulatory inspections and audits by ensuring inspection readiness within ... facilityPerform internal housekeeping auditsPerform analysis on quality indicating data and identifying trendsProvide oversight for trending of quality compliance metricsWork in a collaborative team setting with quality counterparts that include Manufacturing… more
    HireLifeScience (09/12/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …patients and healthcare professionals who report product quality issues Support audits/ inspections as needed Build customer loyalty by providing high quality ... (eg diabetes, obesity, hemophilia, growth hormone disorders) Experience with audits/ inspections preferred Analytical thinking skills required Proficiency in Windows,… more
    HireLifeScience (11/08/24)
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  • BioAgilytix (Durham, NC)
    …at BioAgilytix.Essential ResponsibilitiesPerforms Quality Assurance (QA) audits, inspections (internal/external), and monitoring procedures against standard ... as applicableIssue QA statements for reports as neededAssist in hosting regulatory inspections by acting as scribe and/or reviewing documents and identifying and… more
    HireLifeScience (11/04/24)
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  • 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
    HireLifeScience (11/08/24)
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  • 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
    HireLifeScience (11/07/24)
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  • 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
    HireLifeScience (11/06/24)
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  • Merck & Co. (Durham, NC)
    …activities related to computerized systems are in place and effective. Support regulatory inspection and audit activities as needed. Conduct review of audit or ... inspection reports, responding to findings related to IT applications, automated manufacturing equipment, automated lab systems and infrastructure (at local site) and… more
    HireLifeScience (10/29/24)
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  • 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
    HireLifeScience (10/18/24)
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  • 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
    HireLifeScience (10/16/24)
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  • 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
    HireLifeScience (09/20/24)
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