Track record of writing effective document control procedures and developing employee training solutions set forth by the governing body that conforms t quality assurance standards and/or documentation style guidelines. Successful in spearheading quality improvement initiatives that improve change control and documentation compliance that enhances site and employee quality awareness. Prioritize and complete high level/time sensitive manufacturing and packaging deliverables/projects concepts that will streamline operations, increase revenue and maximize production. Service in numerous cross-functional areas and/or regulated industries that speak t the following:
Controlled Document Implementation
Multiple Project Management
SOP Development and Enhancement
Consent Decree /Training Remediation
Quality Assurance /Quality Control
Problem Solving/Root Cause Analysis
Technical Writing / Subject Matter Expert
Electronic Controlled Document Management
Cleaning Validation and Development
Batch Record Review and Product Release
Change Control and Documentation Compliance
Manufacturing/Packaging Process and Product Development
Six Sigma / Lean Manufacturing Methodologies
CGMP/Industry Regulatory/Compliance Knowledge
KNOWLEDGEABLE IN: ICH E2A, E6, and Q7A GMP for Active Pharmaceutical Ingredients and FDA GCP 21 CFR Part 11, Part 50, Part 54, Part 56, Part 312, Part 314, Part 210, Part 211. cGMP in Manufacturing Processing Packing or Holding of Drugs and Finished Pharmaceutical, Part 600, Part 601, Part 610 General Biological Products Standards and Part 820 Quality System Regulation guidelines. Documentation Practices Controlled Document Formats, Documents Approval Process, Microsoft Office Suite, Lotus Notes, Track-Wise, Adobe Professional, ComplianceWire, SharePoint, JD Edwards, AS400, Systems, Applications Products SAP , Laboratory Information Management Systems LIMS , Enterprise Resource Management ERP , Enterprise Document Management EDM , Quality Management Systems QMS , and Excellence Through Quality EtQ system.
Assist with Consent Decree Remediation by improving quality assurance standards for:
Quality System Element 06 Cleaning Validation
Verification Evidence Binder Lead
- Gather and ensure that audit Quality System Element QSE Workplan completion evidence was ready for compliance and inspection for Enterprise Regulatory Compliance ERC , third party review team, and regulatory authorities.
- Support Right First Time rolling verifications t obtain Consent Decree Quality System Element QSE Workplan certification from third party review team.
- Design and submit evidence binder and electronic documents t the Consent Decree Repository for storage, after each verification segment.
- Change Control Processor
- Initiator and owner/manager of Change Control CC workflow activities/process in the Excellence Through Quality EtQ system.
- Collaborate with affected departments and SMEs including Regulatory t determine scope, impact, and deliverables, including implementation and training strategy.
- Improved compliance by identifying gaps and communicating compliant, effective, and efficient solutions.
- Supported efficient transition from version 1.0 Enterprise Document Management EDM electronic document control management system t version 2.0 by representing Document Control Implementation Team.
- Supported project harmonizing sampling plans and Acceptable Quality Levels AQL / inspection criteria across sites by revising controlled documentation and by partnering with training t develop training curriculum that contributed t successful Quality System Element QSE Work Plan step confirmation and verification.
- Increased regulatory compliance by designing and developing Standard Operating Procedures SOPs for Manufacturing and Packaging Operations contributing t Quality System Element QSE Work Plan step being confirmed Right First Time by third-party Current Good Manufacturing Practices CGMP experts.
- Collaborate with relevant Subject Matter Experts' SMEs and across multiple departments, including design specifications, and system manuals, ensuring quality and technical accuracy of the documentation.
- Utilize quality assurance techniques and/or on site change control s t create, revise, and maintain technical documentation including but not limited t Standard Operating Procedures SOPs , Performance Checklists PCs , Work Instructions WIs , etc. for Manufacturing and Packaging Operations.
- Participate in cross-functional team projects that conduct research t generate clear concise processes and procedures.
Technical Writer, Systems Support Specialist/Service
- Designed Medical Device Service Manual s for the Engineering Department.
- Revised existing technical documents in order t phase out obsolete documentation.
- Collaborate with relevant Engineering Subject Matter Experts' SMEs , t research technical and engineering information, including drawings, design, component and test specifications, and product prototypes, ensuring quality and technical accuracy of documentation.
- Increased employee quality awareness by creating clear and unambiguous step-by-step work instructions WI for complex Engineering processes.
Packaging Technical Writer Clean-Room Environment
- Researched, developed, and revised Standard Operating Procedures SOPs , and other GMP documents for the Packaging Department - Systems, Applications, and Products SAP startup.
- Increased process clarity and efficiency by streamlining training procedures.
- Technical Writer- Vaccine Pilot-Plant Environment
- Reviewed, improved, and maintained existing documentation.
- Improved process clarity and efficiency by assisting with designing, developing, and implementing controlled document.
- Designed and developed a Policy Manual, a Food Safety Manual, and a Quality Manual t meet the requirements of the Code.
- Expanded and enhanced employee training by working with managers t develop personnel training curricula that addressed employee needs, and communicated training system improvements t employees.
- Followed Safe Quality Foods SQF Management System guidelines by conducting Gap Analysis and by determining the Scope.
- Technical Writer - Documentation Resource Subject Matter Expert SME
- Assisted with obtaining Safe Quality Foods SQF Code 2000 Level 2 Certification as a:
- Results: Company attained Safe Quality Foods SQF Code 2000 Level 2 Certification prior t expected timeline.
Documentation Support Specialist - Clinical Trial Project Coordinator
- Organized and facilitated the planning, coordination, tracking, and performance of high-level deliverables against which the Global Clinical Trial Supply measured the clinical trial study product objectives, goals, and budget.
- Ensured that assigned documents were produced in accordance with relevant internal Standard Operating Procedures SOPs and external regulatory guidance, and alerting project teams and line management, in a timely manner, of any definite or potential deviations.
Food Safety Quality Assurance/Quality Control Technical
- Performed QA processes and QC laboratory principles: Microbiological/equipment data, physical data, analytical equipment/assays data, and organoleptic data that supports quality problems Data Management/Audits , processes, and product improvements for final product release.
- Supported the assembly and auditing of batch records, processing, packaging, sanitation, and mock recalls.
- Utilized change control procedures and technical writing skills t lead investigations, determine root cause of atypical events, develop corrective actions t prevent reoccurrence, and determine product quality impact.
- Summarized data and descriptions of events, or investigative work, int reports.
- Authored Level I, II, III supply chain Standard Operating Procedures SOPs Work Instructions WIs , and other Current Good Manufacturing Practices cGMP documents for the Organization Resource Management Department - Laboratory Information Management Systems LIMS startup.
- Completed all phases of document development cycle, including defining document scope and requirements, documentation design, and technical reviews.
- Collaborated with colleagues round-table meetings t identify and implement continuous improvement initiatives, action plans efficiency, productivity, and operational excellence.