With a robust background in the pharmaceutical industry, I bring experience spanning technical writing, project management, and quality assurance.
From 2003 to 2011, I honed my expertise at Pfizer, contributing in multiple capacities. As a technical writer, I specialized in revising batch records and authoring Standard Operating Procedures (SOPs) to ensure compliance and operational clarity. Transitioning into an MES Author role, I developed electronic batch record recipes, streamlining production processes. Later, as a project manager, I led initiatives to optimize manufacturing efficiency, including increasing vial yield and enhancing batch record workflows.
Since 2022, I have been part of Vertex Pharmaceuticals as a QA Specialist, where I oversee the disposition of clinical and commercial drug products. In this role, I ensure the highest standards of quality and regulatory compliance, contributing directly to the production and delivery of life-changing therapies.
This diverse experience has equipped me with a deep understanding of pharmaceutical manufacturing, quality systems, and process optimization, allowing me to excel in dynamic, fast-paced environments.More...
Stacey Johnson
Pharmaceutical Quality Compliance Professional
Verified
I have over 30 years’ experience with regulatory compliance in various industries including Title XIX Medicaid support for nursing home patients, Stafford and Perkins loans assistance for financing higher education, and since 2002, cGMP, Annex 1 and ISO for the pharmaceutical industry, specifically sterile injectable and oral dosage drugs, medical devices and cell and gene therapy. I’m adept at looking at a process or procedure and finding ways to streamline or improve it, as well as reviewing any process for compliance with the governing requirements.More...