all required paperwork/documents to comply with Federal Regulations and FDA Reports variance or deviations from standard procedures... Correctable 20/20 vision Ability to visually inspect small products and print Be able to sit at workstation for up to 50 minutes...
Assurance policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. In this role, a typical day... might include the following: Reviewing and approving batch records from Contract Manufacturing Organizations (CMO) manufacturing...
, such as Batch Production Records (BPR), Standard Operating Procedures (SOP), Works Instructions (WI), and Production Checklists.... This includes equipment preparation, batch dissolution, product synthesis, dispensing of medical radioisotopes, and aliquoting...
and strategic use cases. Beyond delivery, the Lead Software Engineer sets the standard for engineering excellence within the team... across the organization. Key Responsibilities Design, build, and maintain scalable data pipelines and data services (batch...
, including tech transfer plan, standard operating procedures (SOPs), batch records, campaign summary reports, and deviation... and optimization. Knowledge of and hands-on experience with analytical methods used for small molecules and biomolecules (RP-HPLC, SEC...
, and process specifications to ensure all assemblies meet defined tolerances. · Document all manufacturing activities in batch..., standard work) and ability to apply them to daily manufacturing tasks. · Ability to apply critical thinking to troubleshoot...
level technical support and vision, provide task leadership for a small team that supports both the infrastructures... education and work experience. Familiarity with scripting and automation tools, including batch scripts, PowerShell, automation...
), and Catalent’s San Diego facility focuses on early-stage development of small molecule and peptide drug candidates from the bench... products Pre/postproduction cleaning of equipment, supplies and manufacturing area Follow Standard Operating Procedures...
. Taking the initiative to revise and initiate Batch Production Records, Standard Operation Procedures, study protocols... and Standard Operating Procedures. Your responsibilities will encompass various tasks, including production, meticulous...
. We're a small, technically deep team embedded in Axon's TASER pillar. Our work spans hardware telemetry and behavioral... production code at a high standard - strongly typed, comprehensively tested, designed for the people who will maintain it after...