- Aequor (Swiftwater, MN)
- …and other documentation that support site registrations, specific country documentation , and Annual reports. The Regulatory CMC Specialist prepares responses ... Overview of the Position The Regulatory CMC Specialist will work closely with the Regulatory Site...dossiers approved by Health Authorities Prepares and provides Regulatory documentation required for site registration and renewal activities CMC… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to realize your potential? The Position The Senior Specialist , EEO Investigations role will work under the supervision of EEO Investigators ... addressing both internal and external complaints received by the Company. The Sr. Specialist will also be responsible for researching and analyzing data relevant to… more
- Merck & Co. (Millsboro, DE)
- Job Description Description: The Quality Assurance Specialist for Batch Release is responsible for the execution of release tasks and preparation of documentation ... as product is eligible for market, draft, review and approve supporting documentation (ie, Certificates of Analysis, Test Reports, and Product Quality Reports). -… more
- Merck & Co. (Durham, NC)
- …of raw materials, intermediates and finished products.The Quality Operations Laboratory Associate Specialist works with a team of analysts in commercial and pipeline ... activities at the Durham site.--The Quality Operations Laboratory Associate Specialist will be responsible for testing in laboratories using principles of our… more
- Merck & Co. (Rahway, NJ)
- …Disclosure Department of the GCTO organization prepares a variety of regulated documentation in support of the clinical development portfolio and compliance in ... document disclosure, and data sharing with external researchers. - The Specialist (Disclosure Medical Writer) will be primarily responsible for preparing clinical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …treatment of multiple myeloma.Legend Biotech is seeking a Master Data Governance Sr. Specialist as part of the Technical Operations team based in Raritan, NJ. Role ... OverviewWe are actively seeking a proficient Master Data Governance Sr. Specialist with a specific focus on Materials orchestration throughout the End-to-End… more
- Aequor (Thousand Oaks, CA)
- …may include, but are not limited to the following: Management of R&D process documentation per required process (eg Standard Operating Procedure ... and/or revision of materials such as SOPs, Work Instructions, and related business process documentation in conjunction with Subject Matter Experts. Note: these… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking an Operations Support Specialist as part of the Technical Operations team based in Raritan, NJ.Role ... OverviewThe Operations Support Specialist will be part of the Technical Operations team...based on an assigned production shift schedule.Key Responsibilities Support process operations by performing support specific and real time… more
- Aequor (Bothell, WA)
- …problem, and asset management PURPOSE AND SCOPE OF POSITION:The Benchtop Support specialist position will be responsible for providing IT support in our Digital ... activities, Good Manufacturing Practices (GMPs), electronic change management, and process automation in addition to prior manufacturing enterprise systems support.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking Operations Inventory Control Specialist as part of the Technical Operations team based in Raritan, New ... Jersey. Role OverviewThe Operations Inventory Control Specialist will be part of the Raritan CAR-T Operations...as the point of contact for daily distribution of process materials, subject matter expert for operations inventory management… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking CQV Specialist I as part of the Technical Operations team based in Raritan, NJ. ... Tissue Practices.Strong interpersonal and written/oral communication skills.Ability to quickly process complex information and often make critical decisions with… more
- Merck & Co. (Rahway, NJ)
- …conjugates.Facilitate knowledge transfers between development and operations teams.Batch documentation within an electronic laboratory notebook system.Participate in ... with development colleagues on the implementation of novel technologies and process analytical tools.Work collaboratively with pilot plant operations, upstream and… more
- Merck & Co. (Durham, NC)
- …to protect products and patients. Collaborate with stakeholders (eg, System Owners, Process Owners, Data Owners, Business Unit, Technical Units and Subject Matter ... work. Provide the independent quality approval of key qualification/validation documentation such as policies, procedures, acceptance criteria, plans, protocols,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …is responsible for performing reviews of manufacturing and support documentation and records to certify compliance with in-house specifications/standards and ... assess Corrective and Preventive Actions Reviews and approves validation documentation Reviews and assesses deviations; includes tracking, follow-up and… more
- Aequor (Thousand Oaks, CA)
- Fully remoteResponsibilities: Coordinate Global Incoming Quality Process Operations to support Global Process Owner lead. Interface with IQA Network, various ... sites and business partners to ensure maintain process in compliance and alignment. Complete and approve multisite...in a GMP pharmaceutical or medical device industry. Evaluate documentation and operation and documentation according to… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …is responsible for performing reviews of manufacturing and support documentation and records to certify compliance with in-house specifications/standards and ... signature authority for deviation closure Reviews and approves Validation Documentation Reviews and assesses Corrective and Preventive Action Reports Participates… more
- Merck & Co. (Rahway, NJ)
- …order entry, pricing, delivery processing, billing, and payment management.Conduct business process analysis and identify areas for improvement and automation in GTS ... working with trade compliance processes such as classification, licensing, documentation , and reporting; working with pricing procedures, condition types, and… more
- AAOS (Rosemont, IL)
- …for future solicitation of international faculty. Oversees the registration process for International Presidents and ensures that appropriate communications about ... Serves as Staff Liaison to the AAOS Awards Committee and manages the overall process to solicit nominations for the various AAOS Awards. Works closely with Awards… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …through innovation and optimization. The role will support reporting and documentation processes to facilitate efficient campaign operations and ensure successful ... Management: Collaborate with the Campaign Operations Lead to manage specialist work intake, deliverables, prioritize project deliverables/intake, and resource… more
- Merck & Co. (Rahway, NJ)
- …direction of the Audit Director and the Auditor-in-Charge ("AIC"), the Specialist will:Participate in the execution of IT internal audit engagements.Support ... financial or operational, integrated and process audits, both domestic and abroad.Expected to work as a team member on audits with management supervision.Under the… more
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