Experienced in Biotech sector (QA/Technical Writing/Regulatory Affairs)

Quality Specialist and Regulatory Affairs Specialty skills with a strong background in bio-pharmaceutical manufacturing and a proficiency with medical devices. With a deep understanding of various manufacturing processes, I am proficient in effectively communicating and problem-solving with customers to assist project managers in ensuring the expedited release of products to meet monthly sales metrics.

My forte lies in understanding and navigating regulatory landscapes, both domestically and internationally, in accordance with FDA and EMA guidelines. I am well-versed in the evolving regulatory requisites, which empowers me to effectively guide cross-functional project teams towards regulatory compliance.

With my Technical Writing acumen, I have been instrumental in maintaining document templates, style guides, and formatting standards to ensure consistency across technical documentation of protocols and batch records.

Collaboration is a crucial aspect of my work, and I have closely worked with customers and cross-functional teams, including manufacturing, R&D, and Project Management. I excel at providing comprehensive solutions tailored to customer needs.

As a team player, I have worked closely with senior technical writers in creating, editing, and reviewing research reports, manuals, scientific papers, and grant proposals. I am proficient in using SharePoint as a repository for document sharing and live communication of changes.

In summary, I am a dedicated and accomplished Technical Writer with a strong track record in the bio-pharmaceutical industry. I have had to "wear many hats" in my field and possess a keen eye for detail, ensuring compliance with established procedures and GMP guidelines. With my expertise, I am well-equipped to contribute to any organization seeking a skilled Technical Writer with a solid understanding of bio-pharmaceutical manufacturing processes.

Last Resume Update May 22, 2024
Address San Diego, California
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University of New Mexico
Bachelor of Science - Biochemistry
Aug 2013 - Dec 2018

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