• Top Performer who offers proven globally based, quality-driven career results, and who can make decisions to reflect positively on operations in alignment with a company s vision, value, and goals to attain a significant competitive advantage whxxxxxxe complying with cGMOs, standards, and site-specific policies and procedures.
• Visionary Professional who rises above challenges to streamline processes, resolve issues, and generate winning outcomes whxxxxxxe thriving on complexity as a creative-minded leader who attains quantifiable achievements.
• Excellent Communicator who buxxxxxxds synergistic relationships with C-levels, senior-level management and decision-makers, QA teams, multi-department professionals, and customers; who excels within both autonomous and collaborative multi-tasking work environments; and who consistently leads peers with integrity.

Documentation Consultant

  Capitalized on the opportunity to lead forward-thinking project teams in developing results-generating content for training on Global Standard Operating Procedures (SOP), Operational Guides (OG), Policies, User Guides, Templates, Forms, and other associated training materials within the Global Pharmacovigxxxxxxance (GPV) group.

  Consistently ensured curriculum content was in alignment with training materials / deliverables for this industry-leading company specializing in transformation leadership for the life sciences and health care markets.

  Successfully completed on-time implementation of training deliverables.

  Conceptualized and developed dynamic content training metrics and dashboards.

  Developed and / or revised detaxxxxxxed training materials and associated curricula to meet goals.

Quality Assurance Technician Specialist

  Strategically steered review and management of technical documents from a Quality Assurance (QA) perspective for this premier pharmaceutical solutions organization serving 100+ markets, including identifying documentation issues noted during review and communicating to appropriate team(s) that authored drafts.

  Led review and approval of a cross-section of Quality Systems documentation, including closure of investigations, Change Controls, auditing, corrections, evaluations, batch record reviews, and complaint closures.

• Exhibited talent in supporting the Quality Compliance department during FDA and agency inspections, customer queries, and internal audits, along with performing QA review of all work orders, calibration records, and PMs.

  Personally coordinated and analyzed detaxxxxxxed data for a pxxxxxxot project ISPE.

  Successfully served as a valuable Quality Representative for all internal support groups.

  Compxxxxxxed and authored comprehensive Annual Product Reviews (APRs) for all commercial customers.

Quality Assurance Technician Specialist

  Improved new projects development strategy via collaboration with new product development team.

  Ensured continued compliance with cGMOs, corporate, and site-specific policies and procedures internally.

  Acted as the main point of contact, organizer, and chairperson for Material Review Board (MRB) meetings.

Technical Writer I (Contracted Position)

  Utxxxxxxized broad scope of industry knowledge toward developing and / or revising technical documentation (e.g. BOPs, FORMS, JSTMs) and additional relevant documentation and protocols focused on supporting projects for this global pharmaceutical company, including actively working with various functional groups to execute projects.

  Consistently complied with organizational guidelines, proper grammar usage, and format requirements as defined by International Conference on Harmonization (ICH) and governing bodies, and adhered to comprehensive corporate and divisional policies and procedures, specific templates, and Standard Operating Procedures (SOPs).

• 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 skxxxxxxls within a cGMP environment with famxxxxxxiarity with GCP and ICH guidelines / protocols.

  Cost-effectively negotiated with cross-functional areas to achieve project deliverables in tight deadlines.

  Supported the installation of new dry product manufacturing equipment to an onsite operations facxxxxxxity by updating manufacturing process descriptions and creating training documents for operations personnel.

  Proactively assisted with a Medical Device project process transfer onto an onsite operations facxxxxxxity by coordinating documentation approvals to ensure registration runs were completed per plant timelines.

Change Management Plan Specialist (2016)

Six Sigma Lean Professional (2016)

Lean Six Sigma White Belt (2015)

Legal Administration Diploma (2011)

Microsoft Office (Word, Excel, PowerPoint, Outlook) ￨ Visio ￨ SharePoint ￨ Documentum ￨ TrackWise ￨ Compliancewire

Member, Regulatory Affairs Professional Society (RAPS)