Technical Writer

New Yesterday

Position Overview:
The Technical Writer I is responsible for the tracking, management, and completion of Supply Chain Quality Records (including deviations, material recalls, and CAPAs), working closely with subject matter experts (SMEs). This role supports continuous improvement and error prevention initiatives by identifying and addressing recurring root causes. The individual will serve as a Quality Record (PR) Subject Matter Expert (SME) – Level I for the Warehouse/Supply Chain team.
Key Responsibilities:
Initiate, investigate, and complete Minor and Track-and-Trend process deviations Write clear, cohesive, and technically sound reports for an educated but uninformed reader Capture immediate actions and containment steps for events Gather and analyze data across site operations Perform Root Cause Analysis (RCA) and document findings Review and interpret GMP documents (SOPs, logs, Batch Records) Participate in deviation review board meetings and cross-functional problem solving Communicate investigative status updates to stakeholders and management Collaborate with QA (Raw Materials) and other departments for CAPA discussions and comments resolution Observe and collect data from warehouse/lab floor processes to support investigations Adhere to standard timelines and escalate issues when needed Share knowledge and updates openly with team members Demonstrate professionalism and respect in all interactions Perform other duties as assigned
Required Knowledge & Skills:
Technical Expertise:
Experience performing RCA and leading investigations Background in laboratory environments required Understanding of cGMP systems and documentation standards
Computer Proficiency:
Proficient in Microsoft Excel, Word, and databases Experience with TrackWise highly preferred
Communication & Writing:
Excellent technical writing skills; clear, concise, and grammatically accurate Effective communicator with internal and external stakeholders
Decision Making & Problem Solving:
Able to manage multiple investigations and meet deadlines Strong judgment in escalating issues and driving timely resolutions
Teamwork & Initiative:
Collaborative, dependable, and respectful Open to feedback and focused on continuous self-improvement Champions change and demonstrates resilience during challenges
Location:
Houston, TX, United States

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