- Integra LifeSciences (Columbia, MD)
- …of experience in the medical device or similar regulated industry. + Experience with batch record review and product release. + Exceptional attention to ... DUTIES AND RESPONSIBILITIES** + Review Pre, Post and Finished Goods batch records for completeness and accuracy. + Review and approve other assigned… more
- Koniag Government Services (Baltimore, MD)
- …Cyberfusion, Managed File Transfer, connect: Direct) for failed or hung files. + Review batch job documentation for outdated information routinely and when ... & Duties may include, but are not limited to:** + Monitor batch production scheduling environments via multi-distributed platforms. + Process batch … more
- Sumitomo Pharma (Annapolis, MD)
- …and commercial drug substances and drug products; including review and approval of Master Batch Records , Executed Batch Records , batch release, ... organizations and testing laboratories, and with internal and external partners. + Review and approve test results conducted at contract manufacturing and testing… more
- Catalent Pharma Solutions (Harmans, MD)
- …Authors and reviews technical reports, process tech transfer summary reports, master batch records , product and equipment specifications, and protocols in ... change controls + Experience writing and revising standard operating procedures and batch production records + Experience with operating and troubleshooting… more
- Syensqo (Baltimore, MD)
- …housekeeping activities. + Complete all necessary paperwork and electronic documentation (eg batch records , checklists, log sheets, shift ends, etc) + Enter ... the appropriate, documented procedures. + Operate and monitor a continual chemical process, batch reactors, blend vessels, and storage tanks in manual mode and with… more
- Catalent Pharma Solutions (Harmans, MD)
- …starting materials, packaging materials, and intermediate, finished products, and evaluate batch production records . + Ensure Quality approval of specifications, ... responsible for establishing and maintaining the site metrics, management review , and building a Patient First culture at the...Quality Control and is the most responsible person for batch disposition. The Head of Quality will provide project… more
- Actalent (Hunt Valley, MD)
- …and maintain gowning qualification per appropriate SOPs. * Follow SOPs, product batch record instructions, logbooks and forms, and corresponding quality ... Technician of Commercial Drug Products * Perform Formulations /Calculations for Drug Batch ( liquid, powder, or solid) * Compounding / Filtration / Syringe and… more
- Merck (Annapolis, MD)
- …facility. + Author, review , and/or edit operations and technical documentation ( Batch Records , SOPs, Job Aides, training, and engineering documents) to ... support project and future operations. + Identifies and addresses compliance, environmental, safety, and process deviations as appropriate while coordinating with appropriate personnel. + Actively participate in team meetings HAZOPS, waste walkthroughs, 5S,… more