Lora J. Lance

Background

About Lora J. Lance

Over 25 years of experience providing controlled documentation and audit support in the pharmaceutical industry. Solid capability assisting with writing, editing and proofreading Standard Operating Procedures (SOPs) with knowledge of ISO and GXP documentation process. Over 14 years’ experience managing global teams. Expert ability to manage controlled documents and electronic documentation systems. Extensive progressive experience implementing new EDMS systems (Documentum; Veeva), defining Functional Requirements, generating and executing test scripts and validation tasks. Proven ability to collaborate with and support all levels of personnel and management, as well as liaise with client and QA staff during audits. Enforce document compliance and educate staff on document control standards. I have over 28 years in the documentation field, producing data sheets, data books, quality system documents, process flows, newsletters, annual reports, 10K reports, marketing pieces, computer manuals.Experienced proof-reader, writer and editor.I am highly proficient in electronic document management systems (Veeva Vault; Documentum); graphic programs (CorelDraw); flowcharting (Visio); document formatting software (Quark, Word, Publisher); SharePoint.Specialties: Strong QMS background, management of global teams; project management; proficient in collaboration with all levels of management.Extensive experience supervising, coaching and mentoring global staffCertificate; Green Belt, Six SigmaLean Six Sigma methodology certificateGraphics and documentation softwareDocument writing, formatting, proofreading, editing