Documentation Consultant Resume Example
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DOCUMENTATION CONSULTANT
Professional Summary
Detailed-oriented Quality Specialist possessing a unique combination of skills, including business analysis, quality assurance, quality management sytems and applications development experience in top-tier Pharmaceutical and Medical Device organizations.
Skill Highlights
| Microsoft Word Outlook Excel Visio SharePoint Documentum TrackWise Compliancewire |
Professional Experience
Documentation Consultant
March 2016 to July 2016Caci International Inc. － Mount Lebanon , PA
March 2016 to July 2016Caci International Inc. － Mount Lebanon , PA
- Praxis specializes in business transformation leadership for the life sciences and health care industries, known for moving strategic initiatives utilizing experience in the life science and health care industries to assist clients with large-scale change, functional area challenges and program/project management.
- Lead project teams with a goal to develop content for training on Global Standard Operating Procedures (SOP), Operational Guides (OG), Policies, User Guides, Templates, Forms and other associated training materials in The Global Pharmacovigilance (GPV) group.
- Ensured curriculum content is in alignment with training material/deliverables.
- Ensured timely implementation of training deliverables including creation or revision to training materials and associated curricula.
- Developed content training metrics and dashboards.
Quality Assurance Technical Specialist
June 2015 to March 2016Bickford Senior Living － Cedar Falls , IA
June 2015 to March 2016Bickford Senior Living － Cedar Falls , IA
- A premier pharmaceutical solutions organization serving over 100 markets including 41 of the top 50 biotech companies and 48 of the top 50 pharmaceutical companies.
- Effectively managed and reviewed detailed technical documents from a Quality Assurance (QA) perspective.
- Tasked with identifying all documentation issues noted during the QA review and communicating that info to the appropriate team(s) that authored the draft.
- Reviewed and approved a diverse cross-section of Quality Systems documentation including: closure of investigations, Change Controls, audit tasks, driving corrections, effectiveness check evaluations, batch record reviews and complaint closures.
- Successfully ensured and enforced compliance with cGMOs, corporate and site-specific policies and procedures internally.
- Collaborated with New Product Development Team on consistently improving development strategy for new projects.
- Consistently ensured appropriate corrective and preventative actions (CAPA) and developed and implemented and required.
- Efficiently compiled and author Annual Product Reviews (APRs) for all commercial customers.
- Supported Catalent Quality Compliance department during FDA and agency inspections, customer queries and internal audits.
- Successfully coordinated and analyzed data for pilot project ISPE.
- Tasked with performing QA review of Work Orders, Calibration Records and PMs.
- Served as Quality Representative for all internal support groups.
- Acted as the main point of contact, organizer and chairperson for all Material Review Board (MRB) meetings.
Technical Writer I
August 2014 to June 2015ABBVIE － City , STATE
August 2014 to June 2015ABBVIE － City , STATE
- A global pharmaceutical company seeking to discover and advance innovative therapies while meeting the health needs of people and societies around the world.
- Successfully created and revised technical documentation including: BOP's, FORMS, JSTM's and other relevant documentation and protocols focused on supporting departmental projects in a commercial manufacturing environment.
- Efficiently complied with organizational guidelines, proper grammar usage, format requirements as defined by the International Conference on Harmonization (ICH) and fellow governing bodies.
- Additionally, followed corporate and divisional policies and procedures, templates and Standard Operating Procedures (SOP's).
- Successfully negotiated with cross-functional areas such as QC Lab, Operations, Engineering, Validation and Plant QA with a focus on achieving project deliverables under tight timelines Served as a liaison working alongside different functional groups achieving the successful execution of projects.
- Consistently tracked documentation approvals and updated project managers on approval progress internally.
- Gained extensive experience working in cGMP environment and familiarity with GCP and ICH guidelines and protocols.
- Supported medical device project process transfer to on-site operations facility by coordinating documentation approvals ensuring registration runs were successfully completed by plant timelines and schedules.
- Aided in the installation of new dry product manufacturing equipment to on-site operations facility by updating manufacturing process descriptions and creating training documents for operations personnel.
- Supported Medical Device project process transfer onto on-site operations facility by coordinating documentation approvals to ensure registration runs were successfully completed per plant timelines.
September 2013 to March 2014PACIV － City , STATE
- A leading provider of instrumentation, control systems and regulatory compliance services for clients across the globe.
- Technical Writer on Assignment at Eli-Lilly.
Education and Training
Legal Administration Diploma : 2011Academy of Learning － City, State, Canada
Lean Six Sigma White Belt, Management and Strategy Institute, 2015
Six Sigma Lean Professional, Management Strategy Institute, 2016
Change Management Plan Specialist, Management Strategy Institute, 2016
[Type text]
Professional Affiliations
Regulatory Affairs Professional Society
Skills
premier, agency, Calibration, Change Management, develop content, content, Cost Reduction, clients, Documentation, Documentum, driving, focus, FORMS, functional, GCP, internal audits, Leadership, Lean Manufacturing, Regulatory Compliance, manufacturing process, Materials, meetings, Excel, Outlook, SharePoint, Microsoft Word, New Product Development, organizer, organizational, personnel, Policies, Process Improvement, Program Management, progress, project management, protocols, Quality, QA, Quality Assurance, Six Sigma, SOP, Strategy, strategic, technical documentation, Technical Writer, training materials, training material, Type, Validation, Visio, author
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Resume Overview
School Attended
- Academy of Learning
Job Titles Held:
- Documentation Consultant
- Quality Assurance Technical Specialist
- Technical Writer I
Degrees
- Legal Administration Diploma : 2011
Lean Six Sigma White Belt, Management and Strategy Institute, 2015 Six Sigma Lean Professional, Management Strategy Institute, 2016 Change Management Plan Specialist, Management Strategy Institute, 2016 [Type text]
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