Document Author and/or Technical Writer Continuous Process Improvement Verification Evidence Binder Lead

Track record of writing effective document control procedures and developing employee training solutions set forth by the governing body that conforms to 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 to the following:

TECHNICAL PROFICIENCIES

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.

CAREER ADVANCEMENT

Confidential

Technical Writer

• 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 to 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 to develop training curriculum that contributed to 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 to 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 to create, revise, and maintain technical documentation including but not limited to 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 to generate clear concise processes and procedures.

Confidential

Technical Writer, Systems Support Specialist

• Designed Medical Device Service Manual s for the Engineering Department.
  • Revised existing technical documents in order to phase out obsolete documentation.
• Collaborate with relevant Engineering Subject Matter Experts' SMEs , to 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.

Confidential

Packaging Technical Writer

• 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

Confidential

• Reviewed, improved, and maintained existing documentation.
• Improved process clarity and efficiency by assisting with designing, developing, and implementing controlled document.
• Assisted with obtaining Safe Quality Foods SQF Code 2000 Level 2 Certification as a:

Technical Writer

Confidential

• Followed Safe Quality Foods SQF Management System guidelines by conducting Gap Analysis and by determining the Scope.

• Expanded and enhanced employee training by working with managers to develop personnel training curricula that addressed employee needs, and communicated training system improvements to employees.
• Designed and developed a Policy Manual, a Food Safety Manual, and a Quality Manual to meet the requirements of the Code.
  • Results: Company attained Safe Quality Foods SQF Code 2000 Level 2 Certification prior to expected timeline.

Confidential

Documentation Support Specialist

• 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.

Confidential

Food Safety Quality Assurance

• 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 to lead investigations, determine root cause of atypical events, develop corrective actions to prevent reoccurrence, and determine product quality impact.
• Summarized data and descriptions of events, or investigative work, into reports.

Confidential

Technical Writer

• 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 to identify and implement continuous improvement initiatives, action plans efficiency, productivity, and operational excellence.