- Aequor (Thousand Oaks, CA)
- …Manager, this role will be pivotal in identifying, documenting, and adapting documentation and process flows to support system and procedural transitions across ... stakeholders to support the identification, revision, and creation of procedures and documentation that align with system changes. Manage and maintain GMP-compliant … more
- Merck & Co. (Millsboro, DE)
- …record keeping including charts, log books, and all pertinent documentation .Identifies and addresses compliance, environmental, safety, and process deviations as ... operate manufacturing equipment with training-Strong attention to detail and documentation skills are requiredGeneral knowledge of reading, mathematics and computer… more
- Merck & Co. (Rahway, NJ)
- …designed to create a frictionless flow of data from source systems to regulatory documentation .-- - Under the guidance of dCMC Regulatory A uthoring L eadership , ... capabilities to ensure effective digital solution integration and adoption . - Documentation and Project Management Support : The analyst will create detailed… more
- Merck & Co. (Rahway, NJ)
- …to create a frictionless flow of data from source systems to regulatory documentation .- Under the guidance of dCMC Leadership, the Senior Specialist, Digital CMC ... with cross-functional teams to ensure integration of the data into regulatory documentation , supporting consistent data standards and the growth or our regulatory… more
- Aequor (Thousand Oaks, CA)
- …a collaborative attitude to the team. Comfortable with basic computer skills and documentation systems. Familiarity with GMP principles is a plus, but not a strict ... is not limited to, the maintenance of training records, laboratory documentation , written procedures, building monitoring systems and laboratory logbooks. Preferred… more
- Merck & Co. (Durham, NC)
- …and ramp up of facility.Author, review, and/or edit operations and technical documentation (Batch Records, SOPs, Job Aides, training, and engineering documents) to ... cGMP manufacturing and familiarity with regulatory requirements and Good Documentation Practices (GDP)Demonstrated ability to work both independently and as… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …production data and information in a clear, concise, format according to Good Documentation Practices (GDP).Perform tasks on time in a manner consistent with quality ... schedule.Aid in the development of manufacturing processes including appropriate documentation .Drive continuous improvement of manufacturing operations leveraging own observation… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …revision and review of change controls, SOPs, and other documentation .RequirementsBachelor's degree in Engineering, related field, or equivalent experience is ... technical writing skills to author manufacturing SOP's or technical documentation as needed.Experience with process modelling and optimization.Experience with new… more
- Aequor (Thousand Oaks, CA)
- …required, as full training will be provided. Strong attention to detail, good documentation practices (GDocP), and comfort with lab notebooks and SI pages are ... is not limited to, the maintenance of training records, laboratory documentation , written procedures, building monitoring systems and laboratory logbooks. Preferred… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …production data and information in a clear, concise, format according to Good Documentation Practices (GDP).Perform tasks on time in a manner consistent with quality ... in the development of manufacturing gowning processes including appropriate documentation .Drive continuous improvement of gowning techniques and processesmanufacturing operations… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …protocols, reports, risk assessments, technical studies, and any associated documentation in support of computer systems validation, equipment, utilities, and ... and maintenance activities within the siteReview and approve qualification/validation documentation (specifications, protocols, reports).Review and approve periodic review … more
- Merck & Co. (Rahway, NJ)
- …consultants.Perform design and planning reviews from programming through construction documentation .Provide planning and design expertise on campus projects ranging ... Interpersonal Communication, Lease Administration, Real Estate Brokering, Real Estate Documentation , Real Estate Leases, Real Estate Management, Regulatory Compliance,… more
- Aequor (Thousand Oaks, CA)
- …in project management and technical writing is essential. The Controlled Documentation Lead supports end-to-end lifecycle management of R&D controlled documents to ... workflows, perform rigorous QC reviews, and ensure timely and accurate completion of documentation deliverables within the electronic document management system. more
- Aequor (Hicksville, OH)
- …assist in the weighing/mixing of sanitizing agents. Completes required batch documentation records. Assembles and disassembles pumps, mills, kettles, etc. Adheres to ... Personal Protective Equipment (PPE), following lockout/tagout procedures). Follow proper documentation procedures.Job DimensionsNumber of associates:N/AImpact on the organization: Critical,… more
- Merck & Co. (Rahway, NJ)
- …independently conducting and directing the planning, execution, analysis, and documentation of all stages of cell culture process commercialization.Experience with ... model qualification (SDMQ) and process characterization (PC).Experience authoring technical documentation in support of the following: process characterization (PC),… more
- Merck & Co. (Durham, NC)
- …qualification.Maintains qualification within at least 1 suite Reviews and completes documentation to support production activities, including batch record events and ... word processing)- Experience with batch record execution, including good documentation practices- Preferred Experience and Skills: - BioWorks Certificate (working… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …leadership meetings as needed and ensure timely delivery of presentations and documentation . Accurate and state of the art presentation skills, power point, Visio, ... related to ongoing activities. Produce and deliver accurate reports and documentation related to Global QA activities in collaboration with relevant stakeholders.… more
- Aequor (Thousand Oaks, CA)
- …is not limited to, the maintenance of training records, laboratory documentation , written procedures, building monitoring systems and laboratory logbooks. Ability to ... requirements, written procedures and safety guidelines Ability to evaluate documentation /data according to company and regulatory guidelines Ability to organize… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of investigational products with approved vendors and obtains required documentation .Vendor Management -supports Person in Plant (PIP) activities when packaging ... activities at the vendor, including generation of drug orders, review of shipping documentation and obtaining approval to ship.Assists in the creation of SOP's and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …determine immediate path forward for manufacturing issues.Real time review of all documentation , and reporting, in support of process unit operations, in accordance ... with Good Documentation Practices (GDP).Review, revise, or draft Standard Operating Procedures (SOPs).Support on process aseptic process simulations of the processes… more
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