StellenbeschreibungppThe GMP Documentation Specialist supports clinical biologics manufacturing by performing operational review of executed batch records and ensuring documentation supports ALCOA+ standards and GMP expectations. /p pThe role is part of the Operational Excellence team within Manufacturing Operations and focuses on right‑first‑time execution, documentation robustness, and efficient record lifecycle management across paper‑based batch records and Electronic Batch Records (EBR). /p pThis position works closely with shop floor teams, manufacturing SMEs, and Quality while remaining fully embedded in Manufacturing. /p h3Key Responsibilities /h3 h3Executed Batch Record Review /h3 ul liPerform operational review of executed batch records for clinical biologics manufacturing, including: /li liUpstream Processing (USP) /li liDownstream Processing (DSP) /li liWeighing Dispense (WD) /li liReview paper‑based batch records and EBR for alcoa+, data integrity, and GDP compliance /li liReview executed PI sheets in COMET (SAP) to ensure material tracking compliance and identify gaps or inconsistencies in planning BOMs /li liIdentify documentation gaps, errors, or inconsistencies and coordinate timely resolution with manufacturing teams /li liSupport right‑first‑time execution and continuous improvement of documentation practices /li /ul h3Documentation Creation Lifecycle Support /h3 ul liSupport the creation, maintenance, and update of batch record templates (paper and EBR) in collaboration with Process Operations, Tech Transfer, Process MES, and Quality /li liContribute to the creation, revision, and periodic review of manufacturing SOPs, work instructions, and forms /li liSupport implementation of documentation updates into manufacturing operations /li /ul h3Deviation Correction Support /h3 ul liSupport documentation‑related deviations, corrections, and clarification activities /li liProvide input and supporting documentation for deviation investigations related to manufacturing records /li /ul h3Document Handling Archiving /h3 ul liIssue and control floor copies of approved batch records and manufacturing documents /li liSupport GMP‑compliant archiving, retention, and controlled destruction of manufacturing documents in accordance with procedures /li liEnsure traceability and version control of manufacturing documentation throughout the document lifecycle /li /ul h3Required Qualifications /h3 ul liBachelor’s degree or equivalent experience in life sciences, biotechnology, engineering, or a related field /li liExperience working in a GMP manufacturing environment, preferably biologics /li liHands‑on experience with batch record review, manufacturing documentation, or shop‑floor support /li liSolid understanding of GDP principles /li liExperience with paper batch records and/or Electronic Batch Records (EBR) /li /ul h3Preferred Qualifications /h3 ul liExperience in clinical manufacturing environments /li liFamiliarity with USP / DSP operations /li liExperience with WD and solution/media preparation documentation /li liExposure to MES / EBR systems (e.g. PAS‑X, Syncade) /li liStrong attention to detail and structured working style /li liAbility to work cross‑functionally with Process Operations, Tech Transfer, Process MES, and Quality /li liStrong written documentation and technical writing skills /li liProactive mindset with focus on process robustness and continuous improvement /li liStrong German and English language skills required for clear manufacturing communication and preparation, review, and maintenance of GMP‑relevant documentation /li /ul /p #J-18808-Ljbffr