Quality Technical Writer

Job Title: Quality Technical Writer Job Description The Quality Technical Writer supports a quality-focused laboratory environment by preparing clear, accurate, and compliant deviation reports and related documentation. The candidate must have experience with root cause analysis, corrective and preventive action (CAPA) documentation, and technical writing for quality systems in a regulated pharmaceutical or medical device setting. Responsibilities Write detailed deviation reports that clearly describe issues, investigations, and outcomes in a regulated quality environment. Apply structured root cause analysis methodologies such as 5 Whys and Fishbone diagrams to investigate deviations and non-conformances. Document corrective and preventive actions (CAPA), including rationale, implementation steps, and verification of effectiveness. Assist with corrective action investigations by gathering data, interviewing subject matter experts, and synthesizing findings into clear written reports. Obtain technical and process information from cross-functional team members and translate it into accurate manuals, procedures, and other controlled documents. Write clear descriptions of processes, materials, and workflows to support quality and compliance documentation. Support document redlining activities by reviewing, editing, and updating existing documents for clarity, accuracy, and compliance. Collaborate closely with quality assurance and technical writing teams to ensure consistency, completeness, and regulatory alignment of all written documents. Contribute to the documentation of non-conformances and investigations in accordance with internal procedures and FDA expectations. Leverage experience with SAP or similar systems, when applicable, to document and manage quality records and related documentation. Essential Skills 3–5 years of experience in technical writing, preferably in a regulated quality environment. Proven experience writing deviation reports in a pharmaceutical or medical device context. Hands-on experience with CAPA documentation or investigations. Strong knowledge and practical use of root cause analysis tools, including 5 Whys and Fishbone methodologies. Understanding of Good Manufacturing Practices (GMP) and quality assurance principles. Experience supporting or participating in FDA-regulated activities or environments. Ability to document non-conformances, investigations, and quality events with clarity and precision. Excellent writing skills with the ability to translate complex technical information into clear, structured documentation. Experience in the pharmaceuticals industry preferred, and may consider medical device experience. Bachelor’s degree in a scientific discipline or closely related field. Additional Skills & Qualifications Experience with CAPA investigations from initiation through closure. Familiarity with documenting in SAP or similar enterprise quality or document management systems. Experience working with medical device documentation in addition to pharmaceutical processes. Strong attention to detail and ability to maintain consistency across multiple documents and investigations. Ability to work collaboratively with investigators, quality professionals, and technical subject matter experts. Capability to manage multiple open investigations and documentation tasks in parallel within defined timelines. Work Environment This is a contract role expected to run approximately 6–12 months, with a minimum duration through the end of the year due to a high volume of open investigations. The position is based within a contained facility laboratory and the Quality Assurance department, working primarily from a cubicle alongside the quality and technical writing team, including several investigators. The work environment is highly collaborative and interdependent, requiring frequent interaction with the quality department, technical writing colleagues, and other functional departments. The setting follows regulated pharmaceutical or medical device industry standards, with a structured, process-driven culture focused on compliance, documentation quality, and timely closure of investigations. Former employees or consultants are welcome to be considered for this opportunity. Job Type & Location This is a Contract position based out of Irvine, CA. Pay And Benefits The pay range for this position is $40.00 - $40.00/hr. Requirements Eligibility requirements apply to some benefits and may depend on your job classification and length of employment.