Technical Writer

Job Title: Technical Writer
Location: Houston, TX 77047
Duration: 6 Months
Job Type: Temporary Assignment
Work Type: Onsite

Job Description:

• We are seeking a hands-on GMP professional to own quality records, controlled documentation, and operational improvement initiatives supporting onsite Supply Chain and Materials Management operations.
• This role combines technical writing with practical problem-solving and cross-functional coordination. The successful candidate will work directly with warehouse operators, supervisors, Quality, and technical stakeholders to understand how work is performed, develop practical and compliant processes, and drive improvements from initial assessment through approval and implementation.
• Candidates may bring experience in GMP operations, Quality, Materials Management, or technical documentation. Strong writing skills, sound judgment, and demonstrated ability to drive work to completion are essential.

• 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.
• Maintain visibility of record status, due dates, dependencies, and outstanding actions; proactively resolve obstacles and escalate issues requiring leadership decisions.
• Prepare records for review and closure in accordance with site procedures and designated approval responsibilities.

• Lead assigned improvements from problem assessment through process development, controlled documentation, approval, training coordination, implementation, and effectiveness verification.
• Spend time on the warehouse floor observing activities and engaging operators to ensure proposed processes are practical, clear, and executable.
• Bring together Quality, Operations, Engineering, Calibration, Validation, and other stakeholders as needed to establish appropriate requirements and controls.
• Translate agreed requirements into procedures, work instructions, forms, and implementation plans.
• Support initiatives such as counting-scale implementation, transformation 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 that accurately reflect approved operational practices.
• Assess related documents and quality records to identify updates needed when a process changes.
• Coordinate document effective dates, training requirements, and operational readiness to support implementation.

• Establish clear actions, owners, and timelines for assigned records and initiatives.
• Facilitate focused working sessions and follow through on decisions and commitments.
• Provide concise status updates to Materials Management leadership, highlighting risks, overdue actions, and decisions needed.
• Exercise sound judgment in identifying when technical or Quality input is required and obtaining the appropriate approvals.

• 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 turn 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.

• 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.