Technical Writer Quality Assurance
Resume:
Susana Peñalosa
***************@*****.*** • 305-***-****
Summary
Seasoned Technical Writer and QA Compliance Specialist with over 10 years of experience in regulated industries, including pharmaceutical, biotech, and medical device sectors. Proven expertise in authoring, reviewing, and managing controlled documents in alignment with global regulatory standards (FDA, CE MDR, ISO, ICH, and GMP). Skilled in the optimization and remediation of SOPs, Work Instructions, Policies, and technical documents such as Specifications, User Manuals, and Training Materials. Strong background supporting Regulatory Affairs, Quality Assurance, and internal/external audits, including Consent Decree environments. Proficient in leveraging global Electronic Quality Management Systems (eQMS) to enhance documentation workflows and compliance efficiency. Known for transforming complex technical content into clear, user-friendly materials that support business operations, training, and regulatory readiness.
Experience
Technical Writer/QA Manufacturing Operations 03/25 - Present
Johnson and Johnson
Develops new and revised Standard Operating Procedures (SOP), Work Instructions and Computer System Validation (CSV) Test Scripts to deploy new digital capabilities to enable automation of product release processes.
Collaborates with site process owners and experts to revise existing procedures
Manages the change control process in J&J PLM system for all documentation, support training materials development and deployment
Supports draft of User Acceptance Test scripts and engage with project stakeholders to facilitate issue resolution
Tracks progress and report task status
Adheres to documentation quality standards
QMS Sr. Technical Writer 08/22 - 11/24
Terumo Aortic
●Developed, edited, and maintained global GMP documentation and training materials, ensuring compliance with regulatory standards (SOPs, Work Instructions, Manuals, Policies, etc.)
●Supported SMEs in translating complex technical information into understandable formats for new software platforms to ensure documents are clear, concise, accurate and adhere to regulatory and organizational requirements.
●Developed courses on GMP, GDP, and Change Control, ensuring compliance with regulatory and organizational requirements.
●Assisted in regulatory compliance documentation reviews, enhancing document quality and accuracy.
QMS Sr. Technical Writer 01/22 - 7/22
Beam Therapeutics
●Supported global document and training management systems, ensuring compliance with FDA and international regulations.
●Collaborated with stakeholders to maintain compliance with global policies and regulatory requirements.
●Created and reviewed SOPs, Batch Records, Work Instructions, Manuals and Guidelines to facilitate understanding for eQMS users.
●Updated QMS databases to ensure documentation alignment with QMS processes.
Technical Writer/Documentation Management Analyst 12/20 - 11/21
CRISPR
●Authored and reviewed controlled documentation for new facilities, ensuring alignment with regulatory and organizational standards.
●Utilized Smartsheets for tracking document development and project progress.
●Collaborated with stakeholders to ensure document compliance and accuracy.
Technical Writer/Documentation Management Analyst 03/20 - 1/20
Merck, Sharp & Dohme
●Created and delivered internal documentation for eQMS projects, ensuring adherence to regulatory and organizational guidelines.
●Reviewed and updated controlled documents to maintain compliance with global standards.
●Enhanced document quality through meticulous editing and formatting.
Technical Writer/Quality Management System (eQMS) Lead 10/19 - 01/20
Magenta Therapeutics
●Led the transition from paper-based to an electronic documentation system (ETQ Reliance), improving efficiency and compliance.
●Authored policies and procedures adhering to GxP guidelines, enhancing document quality and accessibility.
●Supported Quality Assurance in creating templates and training materials for controlled documentation.
Technical Writer/GMP Documentation Engineer 04/19 - 09/19
Hospira (A Pfizer Company)
●Provided technical writing support for QA Remediation Documentation, ensuring compliance with GxP guidelines.
●Authored and updated documents in a Consent Decree environment, enhancing compliance and document quality.
●Collaborated with QA teams to improve documentation processes and standards.
Technical Writer/PBM Compliance Documentation 12/18 - 04/19
Cigna Express-Scripts
●Supported PHI Compliance Documentation, ensuring adherence to corporate and regulatory requirements and assisted Sales and Management Teams with compliance communications, enhancing document accuracy and clarity.
Technical Writer/Documentation Management Analyst 04/16 - 10/18
Meridian Medical Technologies (A Pfizer Company)
●Provided technical writing and documentation support across multiple functional areas, enhancing document quality.
●Supported eQMS and LMS optimization for controlled documents, ensuring compliance with FDA mandates.
●Collaborated with functional areas teams to improve documentation processes and standardization.
Technical Writer/Documentation Management Analyst 08/15 - 12/15
AstraZeneca
●Supported IT Department during Werum Paperless Manufacturing Execution System MES implementation, providing documentation support for manufacturing and packaging.
●Authored and updated controlled documents to ensure compliance with GMP regulatory standards (SOPs, Work Instructions and Guidelines).
●Collaborated with SMEs to enhance documentation processes and accuracy.
Technical Writer/Documentation Management Analyst 08/14 - 01/15
Actavis Laboratories FL, Inc.
●Provided technical writing support to Quality Assurance and Packaging Departments, enhancing document quality.
●Reviewed and updated Master Packaging Records and Labeling materials, ensuring compliance with regulatory standards.
●Collaborated with teams to improve documentation processes and standardization.
Education
Foreign Languages - Graduate Program
New York University
BA Business Administration
Instituto La Paz (Mexico)
Skills and Accomplishments
●Strong technical writing, reviewing, and editing skills with a focus on regulatory compliance.
●Extensive Electronic Quality Management Systems (eQMS) experience: Veeva Vault, Affinium, Documentum, ETQ Reliance, eReview, LiveLink, SharePoint, Smartsheets, MasterControl and eLearning/Learning Management Systems (LMS).
●Proficient in Microsoft Office applications and advanced document formatting.
●Excellent project management and organizational skills, able to manage multiple tasks effectively.
●Bilingual in English and Spanish with native language proficiency.
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