- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and approve Vendor invoices, including investigator grants and pass through costs. Quality and inspection readiness:Support inspection readiness and ... end-to end delivery of the clinical trial with consistency, quality and per planned timelines. The SDL has the...inspector(s) to address study inquiries throughout course of HA inspection -Ensure trial master file is complete and accurate for… more
- Aptyx (Charlotte, NC)
- …Job Summary: The Quality Inspector I position performs component and product inspection in the quality department in support of the department objectives to ... can create more good things in the world. We are committed to delivering high- quality products and services to our customers worldwide. We are seeking a talented … more
- Aequor (Framingham, MA)
- …skills: - Minimum of 2 years of experience in GMP, can be in quality , manufacturing. - Must have inspection experience process, must have previous experience ... to in-house specifications and government regulation. Establish auditing requirements, quality standards and test methods in accordance with regulations and… more
- Aequor (West Greenwich, RI)
- …end-user requirements, establish validation requirements and Change Control strategy. Supports inspection readiness activities across Quality Control, and site ... audits and inspections. Monitor and trouble shoot analytical benchtop equipment. Lead projects and project planning responsibilities to ensure on time implementation of analytical instruments. Responsible to implement projects on time and on budget. Complete… more
- Genmab (NJ)
- …love to have you join us!The Role The Associate Director, External Data Quality Management, is a strategic leadership role supporting high- quality execution of ... clinical trial portfolio. This individual is accountable for driving the strategy, quality , and integrity of external data across the clinical programs.The Associate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diligence assessments of GMP facilities and or CMOs as deemed necessary. Ensure inspection readiness are adequately performed and may support and/or lead regulatory ... inspection activities at DS facilities and / or CMOs....collaboration with DS affiliates to promote a culture of quality that drives performance and teamwork.Responsibilities:GMP Audit: Support the… more
- Repligen (Clifton Park, NY)
- OverviewAre you detail-oriented, passionate about quality , and looking for a hands-on role in a fast-paced environment? Repligen's Clifton Park facility is looking ... for a Quality Inspector I to join our 2nd shift team...and interpret engineering drawings, specifications, and purchase orders.Accurately document inspection results using Microsoft Office and other software.Use precision… more
- Aequor (Thousand Oaks, CA)
- …performs routine laboratory testing and related activities in support of Quality Control operations. The role requires adherence to current Good Manufacturing ... equipment as required. Maintain laboratory reagents and maintain an inspection ready area Maintain complete and compliant laboratory documentation, including… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …multiple myeloma.Legend Biotech is seeking Head of Compliance as part of the Global Quality team based in Raritan, NJ. Role OverviewThe Head of Compliance will be ... responsible for providing quality oversight over the...addition, this role will support Compliance initiatives, such as inspection readiness, metrics implementation and review, overall regulatory compliance… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …fieldSolid understanding of regulatory requirements, policies and guidelinesExperience with Quality Control document reviews and regulatory inspection ... Biotech is seeking QC Specialist, Lab Services, II/III as part of the Quality team based in Raritan, NJ. Role OverviewThe QC Specialist, Lab Services is… more
- Merck & Co. (Rahway, NJ)
- …in an electronic system.- Knowledge of PAS-X is preferable.GMP: Follow established inspection batch records, protocols and quality standards to ensure compliance ... to cross-train in other parts of the process including thaw, formulation, visual inspection , and sterile supply. These individuals are expected to partner with, and… more
- Merck & Co. (Rahway, NJ)
- …in an electronic system.- Knowledge of PAS-X is preferable.GMP: Follow established inspection batch records, protocols and quality standards to ensure compliance ... closely with team members and partner groups including formulators, engineers, Quality , Safety, and Facilities management to drive overall success and performance… more
- Merck & Co. (Durham, NC)
- …our patients. We work in the manufacturing plants with a "Safety First, Quality Always" mindset, striving for continuous improvement, and earn our right to produce. ... local plants connected to our global manufacturing network supplying the highest quality of raw materials, intermediates, and finished products.This role is within a… more
- Aequor (Hicksville, OH)
- …induction sealers, robotic case packers, laser printers and aggregation labeling, inspection , printers, and data management. Supports and assists in the installation ... system files, and operating systems. Assist with review, investigation and inspection of local machine data, system configuration management, version control and… more
- Merck & Co. (Rahway, NJ)
- …quality requirements on GCS equipment and infrastructureSupport Permanent Inspection Readiness and Continuous Improvement expectations.Manage global small capital ... collaborate regularly with upstream operations (eg manufacturing, devices) as well as Quality and Safety in ensuring GCS readiness to support the future… more
- Cipla (Hauppauge, NY)
- …thereof based on business needs. Responsibilities/ Accountabilities Help with the Inspection of carriers/trailers of inbound and outbound shipments. Escorts drivers ... with BOL, Packing List, PO, etc. Moves materials as required for sampling, inspection , status label changes, etc. Assist with the move of materials from Quarantine… more
- Aptyx (Taunton, MA)
- …and Good Manufacturing Practices (GMP). This role is critical to ensuring high- quality products are manufactured safely, accurately, and efficiently in a regulated ... in a fast-paced manufacturing setting and are committed to quality , teamwork, and continuous improvement.Essential Duties and Responsibilities Perform assembly,… more
- Bayer (Whippany, NJ)
- …enabling cross-functional teams to be accountable for the delivery of high quality , ethical standards of service. The role combines digital expertise with the ... mock audits. Support the function throughout the audit and inspection process as well as assist with any corrective...forward to be accountable for the delivery of high quality , ethical standards of service across the lifecycle of… more
- Merck & Co. (Durham, NC)
- …our patients. We work in the manufacturing plants with a "Safety First, Quality Always" mindset, striving for continuous improvement, and earn our right to produce. ... local plants connected to our global manufacturing network supplying the highest quality of raw materials, intermediates, and finished products. This role is within… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …multiple myeloma.Legend Biotech is seeking QA Investigations Lead I as part of the Quality team based in Raritan, NJ. Role OverviewThe QA Investigation Lead is an ... Investigation Excellence Team. The QA Investigations Lead is responsible for providing quality oversight and guidance during the investigation of events that occur… more
