Technical Writer
About The Position
The Technical Writer will support onsite Supply Chain and Materials Management operations in a regulated environment. The role combines technical writing, quality-record ownership, practical problem-solving, and cross-functional coordination. The successful candidate will work directly with warehouse operators, supervisors, Quality, and technical stakeholders to understand operational practices, develop compliant and practical processes, and drive improvements from assessment through approval and implementation. The position owns Materials Management deviations, CAPAs, and change controls in TrackWise; leads operational process improvements; and manages controlled-document updates. Work includes gathering evidence, facilitating investigations and root-cause analysis, authoring and revising SOPs, work instructions, and forms, coordinating reviews, approvals, training readiness, implementation, and effectiveness verification. The role routinely engages with warehouse operations onsite in Houston.
Requirements
- Relevant experience in a cGMP pharmaceutical, biotechnology, or comparable regulated environment.
- Demonstrated experience authoring controlled procedures and supporting or owning deviations, CAPAs, or change controls.
- Ability to understand operational activities through direct observation and discussions with operators and subject matter experts.
- Strong technical writing skills, including the ability to translate complex requirements into clear, usable instructions.
- Demonstrated ability to manage multiple priorities and drive cross-functional actions to completion.
- Working knowledge of GMP documentation practices, investigations, root-cause analysis, and change management.
- Proficiency with Microsoft Word and Excel and experience using electronic quality and document management systems.
- Bachelor's degree in a relevant field or an equivalent combination of education and relevant experience.
- Ability to work onsite in Houston and routinely engage with warehouse operations.
Nice To Haves
- Experience in pharmaceutical or biotechnology warehousing, Supply Chain, or Materials Management.
- Experience with TrackWise and controlled document approval workflows.
- Experience implementing operational changes involving equipment, material handling, electronic workflows, or warehouse controls.
- Familiarity with SAP or another enterprise inventory management system.
- Experience coordinating process implementation, training readiness, and effectiveness verification.
Responsibilities
- Own and drive Materials Management deviations, CAPAs, and change controls through completion in TrackWise.
- Gather evidence, facilitate investigations and root-cause analysis, and develop clear documentation with input from relevant subject matter experts.
- Coordinate impact assessments, corrective and preventive actions, implementation evidence, and effectiveness checks, as applicable.
- Track record status, due dates, dependencies, and outstanding actions; resolve obstacles proactively and escalate issues requiring leadership decisions.
- Prepare quality records for review and closure in accordance with site procedures and designated approval responsibilities.
- Lead assigned process improvements from problem assessment through process development, controlled documentation, approval, training coordination, implementation, and effectiveness verification.
- Observe warehouse activities and engage operators to ensure proposed processes are practical, clear, and executable.
- Coordinate with Quality, Operations, Engineering, Calibration, Validation, and other stakeholders to establish appropriate requirements and controls.
- Translate agreed requirements into procedures, work instructions, forms, and implementation plans.
- Support initiatives such as counting-scale implementation, conversion of material transfer sheets to an electronic workflow, and removal of cardboard from warehouse operations.
- Own the Materials Management document-update portfolio, including prioritization, progress tracking, stakeholder review, and approval coordination.
- Author and revise SOPs, work instructions, forms, and supporting documents to reflect approved operational practices.
- Assess related documents and quality records to identify updates needed when processes change.
- Coordinate document effective dates, training requirements, and operational readiness to support implementation.
- Establish clear actions, owners, and timelines for assigned records and initiatives; facilitate working sessions and follow through on decisions and commitments.
- Provide concise status updates to Materials Management leadership, highlighting risks, overdue actions, and decisions needed.
- Identify when technical or Quality input is required and obtain appropriate approvals.
