KBI Biopharma Document Coordinator - Manufacturing Sciences And Technology in Boulder, Colorado
Job summaryThe Document Coordinator is responsible for ensuring all documentation isready for NPIs/PRIs. This includes ensuring formats are consistent withhigh-quality document outputs. They serve as the primary point of contact forall cross-functional reviews and coordinating standard/templateimplementation.Job ResponsibilitiesPrimary ResponsibilitiesDevelop document schedule and ensure adherence to timelines.Set up of document folders for NPIs/PRIs in SharePoint.Initiate drafts for all NPI documents.Maintain document alignment with current document standards and templates.Own minor document updates caused by CAPAs.Member/Owner of Document Standards Team.Reviews and updates formatting within documents to ensure consistency acrossdocuments.Owns Dispensing Batch Tickets.Owns Processing Batch Tickets.Organizes client comments, sends updates to client with feedback fromtechnical owners.Responds to reviewers and updates documents based on reviewer comments forformats and non-technical corrections.Works with document owners on technical updates to ensure work is complete.Secondary ResponsibilitiesOwner of CAPAs with only document updates, including ownership of thedocument updates.Owner of all "standard" Solution Prep Records.Drive improvements in the document drafting/reviewing/approving process.Owns QC Batch Tickets.Owns Routine Sample Plans with input from PD/MST Technical leads.Owns Non-routine Sample Plans with input from PD/MST Technical leads.Minimum RequirementsKnowledge, Skills, AbilitiesCollege Degree preferably in a technical subject with a minor or advancedbusiness degree.Language AbilityThe candidate will need to be able to write up and present process developmentand manufacturing results in a clear and concise manner.Math AbilityThe candidate requires a demonstrated grasp of basic mathematics.Physical DemandsThis position involves predominantly office... For full info followapplication link.KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversifyits work force. Therefore, all qualified applicants, regardlessof race, color, national origin, religion, gender, genderidentity, sexual orientation, age, disability or Vietnam veteranstatus, are strongly encouraged to apply.