Quality
Technical Writing
At the start of my career at Genentech, there was no dedicated Manufacturing Tech Writing group; updates to SOPs and Batch Records were typically handled by manufacturing supervisors and a few associates. Recognizing opportunities for improvement, I began revising and enhancing procedures during my spare time around processing. My contributions were well-received, and I was soon recruited into the newly established Tech Writing group.
In this role, I collaborated closely with research scientists to develop accurate and comprehensive SOPs and Batch Records, ensuring their processes were ready for seamless transfer into Manufacturing. This experience not only strengthened my technical writing skills but also demonstrated my ability to bridge the gap between research and production—an expertise I have continued to apply and refine throughout my career.
Compliance
I have a strong understanding of compliance with regulatory requirements from various agencies, including the FDA, EMA, and other global health authorities, as well as adherence to industry guidelines such as ICH, cGMP, and ISO standards. My experience includes auditing Quality Manuals to ensure alignment with these regulations and standards, identifying gaps, and implementing corrective measures to ensure full compliance.
I have authored, reviewed, and approved numerous Deviations, CAPAs (Corrective and Preventive Actions), and investigation reports, ensuring robust root-cause analysis and effective resolution of issues to prevent recurrence. My work has also involved meticulous review of internal and external manufacturing documents, including Batch Records and supporting documentation, to support lot release and ensure product quality and safety.
In addition, I have been actively involved in multiple audits conducted by regulatory agencies and third-party auditors. My responsibilities have included serving as a key point of contact, preparing documentation, addressing questions from auditors, and implementing post-audit corrective actions to maintain and improve compliance. My comprehensive approach to compliance has consistently supported successful inspections and ensured alignment with evolving regulatory expectations.
Quality Systems
I have extensive experience working with a variety of Quality Management Systems (QMS) which has allowed me to effectively manage and streamline quality processes. In addition to using these systems, I have often been responsible for authoring work instructions and creating standard operating procedures (SOPs) to ensure that best practices and regulatory requirements are clearly communicated to my colleagues. Some of the key QMS systems I have worked with include Veeva Vault QMS, ComplianceWire, JDE Enterprise, MasterControl, TrackWise, and SAP Quality Management (QM).
Throughout my career, I have consistently created clear, concise work instructions, SOPs, and training materials to ensure that all team members are aligned with quality standards and compliant with regulatory guidelines. My experience with these various QMS systems has allowed me to streamline processes, improve operational efficiency, and contribute to the successful delivery of high-quality products.
