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...
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...
. 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...
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 equipment according to batch records, user manuals, design parameters, standard operating procedures, and work instructions... in their assigned area, Small Molecule, Hybrid, or Biologics, and educates the team on the proper operation of the facility. This role...
. CRH operates with a decentralized, diversified structure, letting you work in a small company environment while having the... PPE to perform maintenance or repair to plant components (ex: silo, drag slats, traverse, bag house, elevators, batch...
efforts and executing on small to large enterprise level applications by translating functional requirements, project... with development teams to plan testing efforts and oversee testing execution on small to large enterprise level applications...
and drug product manufacturing across multiple product modalities (e.g., small molecule, biologics, gene therapies) including... and maintain comprehensive process documentation including process flow diagrams, risk assessments, standard operating procedures...