Position Summary

We are seeking a detail-oriented Technical Writer to support the Supply Chain organization within a regulated biopharmaceutical manufacturing environment. This position will be responsible for developing, reviewing, and maintaining technical documentation related to supply chain operations, material management, inventory, and manufacturing support activities.

The Technical Writer will also support the documentation and investigation of data deviations, discrepancies, and documentation errors, ensuring that records are accurate, complete, traceable, and compliant with applicable GMP requirements.

Key Responsibilities

• Prepare, write, edit, and maintain technical documents, procedures, work instructions, reports, and other controlled documentation.
• Support Supply Chain with documentation related to materials, inventory, purchasing, receiving, warehousing, shipping, and production support.
• Review documentation and data for accuracy, completeness, consistency, and compliance with established procedures.
• Investigate and document data deviations, discrepancies, errors, and documentation issues.
• Assist with deviation investigations by gathering information, reviewing records, identifying contributing factors, and documenting findings.
• Support root-cause investigations and development of appropriate corrective and preventive actions (CAPA).
• Prepare clear and concise deviation summaries, investigation reports, impact assessments, and supporting documentation.
• Work with Supply Chain, Quality, Manufacturing, Warehouse, and other cross-functional teams to obtain and verify information.
• Ensure documentation follows Good Documentation Practices (GDP) and applicable GMP requirements.
• Review and revise SOPs, work instructions, forms, templates, and other controlled documents.
• Maintain document revisions and ensure changes are accurately incorporated into controlled documentation.
• Assist with audit and inspection readiness by ensuring documentation is complete, organized, and readily retrievable.
• Identify documentation trends and recurring data issues and communicate potential risks to management and Quality.
• Ensure technical documentation accurately reflects current processes and approved procedures.
• Maintain confidentiality and integrity of company and manufacturing data.
• Perform other documentation and Supply Chain support duties as assigned.

Required Qualifications

• Bachelor's degree in Technical Writing, English, Communications, Life Sciences, Supply Chain, Business, or a related field, or equivalent experience.
• 2+ years of technical writing, documentation, quality, supply chain, manufacturing, or regulated-industry experience.
• Experience working with deviations, discrepancies, investigations, or data/documentation errors strongly preferred.
• Experience in a biopharmaceutical, pharmaceutical, medical device, biotechnology, or other regulated manufacturing environment preferred.
• Strong technical writing, editing, proofreading, and documentation skills.
• Ability to interpret technical information and translate it into clear, concise documentation.
• Strong attention to detail and ability to identify inconsistencies or errors in data and documentation.
• Understanding of GMP, GDP, data integrity, and controlled documentation principles.
• Strong organizational and time-management skills.
• Proficiency with Microsoft Office, particularly Word and Excel.
• Ability to work effectively with cross-functional teams and communicate with personnel at all levels.

Preferred Experience

• Experience with deviation/CAPA systems such as TrackWise, Veeva, MasterControl, or similar systems.
• Experience with electronic document management systems (EDMS).
• Experience supporting FDA-regulated or GMP manufacturing operations.
• Familiarity with data integrity principles such as ALCOA+.
• Experience reviewing batch records, inventory records, material documentation, or supply chain records.
• Knowledge of ERP systems such as SAP, Oracle, or similar platforms.

Key Skills

Technical Writing | Deviation Investigations | Data Integrity | GMP/GDP | Supply Chain Documentation | SOPs | CAPA | Root Cause Analysis | Document Control | Data Review | Quality Systems | Microsoft Office

Work Environment

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