Shamir Dominique
North Attleboro
Summary
Senior Quality Assurance and Documentation Specialist with nearly four years of experience in supporting GMP-compliant documentation systems at a prominent RNAi biotechnology company. Skilled in the lifecycle management of batch records and controlled documents, encompassing issuance, effective approval, archival, and supporting documentation for change controls. Demonstrated expertise in facilitating successful FDA inspections, developing process optimization dashboards within Veeva, and overseeing the consolidation of standard operating procedures and work instructions. Currently pursuing dual graduate degrees in Drug Development and Business to facilitate long-term objectives in Quality Assurance leadership and biotechnology consulting.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Senior QA/Document Control Specialist
Alnylam Pharmaceuticals
Norton/Alewife
06.2022 - Current
- Served as the final approver and release point for GMP documents prior to becoming effective, while managing document updates during product lifecycle transitions, including, but not limited to, SOPs, batch records, and work instructions.
- Logbook issuance, review, and archival.
- Ensure quality, compliance, and employee safety objectives through ongoing monitoring via reports, dashboards, Excel, issuance, and controlled archival of batch records, with ensured compliance to document lifecycle procedures and GMP standards.
- Designed and maintained real-time dashboards in Veeva to improve transparency, readiness for audits, FDA inspections, and to assist in the management of new product introduction, controlled copy distribution, and documentation timeliness for multiple departments.
- Successful integration of multiple projects for GMP documentation, draft to effective lifecycles, and configurations for Veeva with external employees.
- Provided critical support for FDA inspections and audits via multiple back and front room capacities, including audits for international regulatory bodies.
- Coordinated relocation of the document room and harmonization of EDMS procedures across two sites, without deviation from quality timelines.
- Conducted internal QA workshops and trained manufacturing support staff on controlled copy access and EDMS compliance.
- ASQ certified: GMP and GXP exemplar Lead Auditor Certification: ISO 9001, 3001, 19011, 13485, 21 CFR 210.
- Acted as QA liaison for QC and production teams while supporting, driving, and accomplishing multiple projects, leading to the commercialization of the site, new product release, and ongoing product introduction.
Protocol Documentation Specialist
Sanofi Pharmaceuticals
Remote
06.2021 - 08.2022
- Drove & Enforced critical pathways, version control procedures and contributed to the EDMS migration project under compliance deadlines.
- Train manufacturing and technical writers on the use of e-docs (GEODE, GenDoc) for the publication of pharmaceutical protocols.
- Authored, formatted, and drove technical protocols and SOPs supporting manufacturing and validation processes, both USP and DSP, including PrePPQ and supporting documents.
- Coordinated and independently provided SME-level support for all lifecycle processes, including revisions, approvals, discrepancies, and obsolescence for the manufacturing of pharmaceutical products, both pilot and at scale.
- Participated in harmonization of controlled documents across multiple functional units.
Childcare Provider
Kids in Distress
Fort Lauderdale
04.2019 - 12.2021
- Developed, implemented, and adjusted schedules and routines for weekly child care.
- Observed for signs of emotional or developmental trauma within children while appropriately communicating any misconduct to any parent or guardian.
- Recorded children's progress and routines and created daily plans to form good habits and the facilitation of a healthy growing environment.
- Performed all other duties involved in childcare including but not limited to doctors visits, overnight stays, daily hygiene, tutoring, and contributions to a safe yet fun environment.
Lead Pharmacy Technician
CVS Health
Stoughton
01.2019 - 12.2021
- Received and verified daily incoming drug inventories, report discrepancies and log items into inventory system.
- Verified and troubleshoot all customer claims including meetings with providers, insurance, shipping, & timely delivery of prescriptions.
- Drove vaccination metrics & acted as lead throughout COVID-19 Pandemic.
Lead Research Coordinator II
Partners Healthcare
02.2019 - 06.2021
- Served as Lead Coordinator for COVID-19's reactivation strategy, involving physician approval and interdepartmental communication.
- Drove communication and worked daily with a number of CIs, scientists, and clinicians on precision-based medicine and recruitment to bring in over 50,000 participants to the study.
- Oversaw daily operations while simultaneously training, assisting, and collaborating with research coordinators on clinical developments such as specimen collection, participant tracking, study consents, and analytical skills.
- Trained, managed staff, and operated under clinically sterile and lab-sterile environments to facilitate Partners' Biobank research.
Research Assistant
Trinity Spine Center
Odessa
01.2013 - 12.2018
- Created and implement new research methods to explore mechanisms of biological processes.
- Designed research and experimental studies, while executing research techniques including but not limited to, assays. synthesizers, spectrophotometry, and storage.
- Coordinated spinal injection schedule and follow up based on patient interdisciplinary plan, assessment, and program specific SOP's for studies.
Education
MBA - Entrepreneurial Marketing
Johns Hopkins University
12-2026
MS - Drug Development
Johns Hopkins University
12-2025
Bachelor of Arts - Biomedical Sciences
University of South Florida
Tampa, Florida05.2016
Skills
- GMP/GxP documentation systems (eDMS)
- Research protocol development
- Final QA document approval
- Quality assurance
- Audit and FDA inspection support (back room)
- Project management
- Operational Improvement
- Document lifestyle governance and procedure
- CAPA/ Deviation Support (Documentation)
- Lifecycle Processes
- Batch Record Issuance to Archival
- Microsoft Suite
- Cross-functional collaboration (QA, QC, FAC, MFG)
- Clinical & Quality Based Analytical Skills
- Document Room Transitions & Compliance
- Logbooks issuance to archival
- Strong Communicator
- Document control
- Records management
- Good clinical practice
- Site management
- Protocol development
- Risk assessment
- Ethical guidelines adherence
Certification
ASQ Exemplar - Lead Auditor Certification, 2023-12-01
Personal Information
Title: Senior QA / Documentation Specialist
Languages
- Haitian Creole, Native or Bilingual Proficiency
- American English, Native or Bilingual Proficiency
Volunteer Experience
- Volunteer (stocking), Cupboard of Kindness, 2022-12-01, Present, Norton, MA, Unload trucks and stock shelves on behalf of the Norton food pantry.
- Nutritionalist, Palm Bay Hospital, 2012-05-01, 2013-06-01, Palm Bay, Prepared & Delivered food to patients based on dietary restrictions.
- Community Volunteer, Habitat for Humanities, 2013-04-01, 2016-12-01, Tampa, FL, Aided in community clean up including road clean up, implementation of community gardens, the establishment of shelters, and youth groups.
- Respite Sitter / Volunteer, Kids in Distress, 2015-12-01, Present, Fort Lauderdale, FL, Provide volunteer respite childcare for children ages 1 - 18 limited to day events/ sits not requiring overnight stay.
- Undergraduate researcher, University of South Florida, 2013-01-01, 2015-12-01, Conducted various studies during my undergraduate career including a prosthetic limbs study aiding in the daily functionality for amputees.
Hobbies and Interests
- Dogs
- Nature
- Beaches
- Music
- Art
- Travel
Languages
English
Native/ Bilingual
Haitian creole
Native/ Bilingual
Affiliations
- ASQ/ISPE
- Phi Beta Sigma Fraternity Inc.
- Volunteer Organizations (Cupboard of Kindness, Kids in Distress, Green Teams)
Accomplishments
Johns Hopkins Norway Leadership Development Expedition (2025)
References
References available upon request.
Timeline
Senior QA/Document Control Specialist
Alnylam Pharmaceuticals
06.2022 - Current
Protocol Documentation Specialist
Sanofi Pharmaceuticals
06.2021 - 08.2022
Childcare Provider
Kids in Distress
04.2019 - 12.2021
Lead Research Coordinator II
Partners Healthcare
02.2019 - 06.2021
Lead Pharmacy Technician
CVS Health
01.2019 - 12.2021
Research Assistant
Trinity Spine Center
01.2013 - 12.2018
MBA - Entrepreneurial Marketing
Johns Hopkins University
MS - Drug Development
Johns Hopkins University
Bachelor of Arts - Biomedical Sciences
University of South Florida
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