Clinical Documentation & Compliance Specialist

TAMMY SMITH

*********@*******.*** 512-***-**** Carlisle, MA

CLINICAL DOCUMENTATION & COMPLIANCE SPECIALIST

Detail-oriented healthcare documentation professional with 8+ years of experience supporting clinical research operations, EHR systems, and regulatory compliance in GMP/GCP environments. Skilled in document management, training administration, TMF maintenance, and cross-functional support. Proven ability to streamline processes, ensure audit readiness, and bridge communication across departments. Certified in both ISO-9001, OSHA-10, and AI (artificial intelligence).

Professional Experience

Lonza Lexington, MA

Document Control Specialist & Training Admin Jan 2022 – Aug 2025

- Processed daily document change requests and managed formatting review in compliance with GMP standards.

- Delivered onboarding and training access across GMP and non-GMP staff.

- Supported manufacturing runs by issuing controlled copies and resolving training discrepancies.

- Organized and archived documents across hospital, clinic, and pharma settings.

Takeda Pharmaceuticals Lexington, MA

Process Excellence & Learning Systems Specialist Mar 2021 – Oct 2021

- Administered LMS and DMS systems, resolved user issues, and maintained audit compliance metrics.

- Reviewed document change requests, verified formatting/versioning, and managed workflows with QA and R&D.

- Collaborated with SMEs and content experts to ensure training compliance during audits.

Seqirus Cambridge, MA

Quality Project Associate – Clinical Quality Assurance Mar 2020 – Mar 2021

- Maintained QA filing systems and documentation for audits and inspections.

- Coordinated internal/external audit prep, CAPAs, and deviation management.

- Led documentation for CQA metrics, vendor contracts, and budget reporting.

- Served as department LMS admin and SharePoint documentation support.

Takeda Pharmaceuticals Lexington, MA

Lab Services Manager & Project Manager – Medical Affairs Jan 2017 – Mar 2020

- Managed lab logistics and coordinated global biomarker testing and patient sample delivery.

- Handled stakeholder escalations, issue tracking, and vendor performance.

- Supported Pharmacovigilance reporting and regulatory documentation processes.

- Facilitated global project meetings and collaborated with internal and external teams.

Awards & Training

- Community Leadership Award, City of Milwaukee, WI (1992)

- Regularly trained in GxP, EHR systems, LMS/DMS platforms

Technical Skills

Veeva Vault • myQumas • SABA LMS • EDMS • TrackWise • Microsoft Office Suite • SharePoint • Adobe Pro • Blueprint reading• Geometric Design and Tolerances• Shop Math

Education

Biology/Chemistry – BA- Alverno College

Biomedical degree- MS- Barry University

Allopathic Medical Degree- MD- Medical University of Lublin Poland

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