Technical Writer Biopharma (Data Deviations & Supply Chain Deviations) in Tustin

Job DescriptionJob Description

Technical Writer – Manufacturing Quality Systems

Position Summary

The Technical Writer is responsible for preparing, reviewing, and managing documentation within the Quality Management System (QMS) to support manufacturing and quality operations in a GMP-regulated environment. This role investigates quality events, authors clear and compliant records, collaborates with cross-functional teams, and ensures documentation is completed accurately and within established timelines.

The ideal candidate has excellent technical writing skills, strong analytical abilities, and experience working in pharmaceutical, biotechnology, or GMP manufacturing environments.

Essential Duties & Responsibilities

• Author and manage Quality Management System (QMS) records, including:
• • Deviations
  • Out-of-Specification (OOS) investigations
  • Out-of-Limit (OOL) investigations
  • Out-of-Trend (OOT) investigations
  • Calibration-related investigations
• Conduct thorough investigations to determine root cause by reviewing manufacturing documentation, laboratory data, calibration records, procedures, protocols, reports, and batch records.
• Gather information from subject matter experts (SMEs), operators, engineers, and quality personnel to accurately document events and investigations.
• Write clear, concise, and technically accurate investigation reports while maintaining compliance with Good Documentation Practices (GDP).
• Ensure all documentation complies with current Good Manufacturing Practices (cGMP), FDA regulations (21 CFR Part 210/211), company procedures, and quality standards.
• Manage assigned investigations from initiation through final approval and closure while meeting established timelines.
• Identify corrective and preventive actions (CAPAs) and assist in documenting implementation plans.
• Evaluate manufacturing and quality processes to identify opportunities for continuous improvement and recommend process enhancements.
• Perform statistical analysis and data trending to support investigations and determine root cause.
• Revise documentation based on feedback from Quality Assurance, management, and technical reviewers.
• Coordinate with cross-functional departments including Manufacturing, Quality Assurance, Quality Control, Engineering, Validation, and Regulatory Affairs.
• Support inspections and audits by ensuring documentation is complete, accurate, and readily available.
• Perform additional duties as assigned.

Qualifications

• Bachelor's degree in Life Sciences, Biology, Chemistry, Biochemistry, Biotechnology, Engineering, Technical Writing, or a related scientific discipline.
• 2+ years of experience in technical writing, quality systems, manufacturing investigations, or document control within the pharmaceutical, biotechnology, medical device, or regulated manufacturing industry.
• Experience working in a GMP-regulated environment .
• Knowledge of FDA regulations, cGMPs, Good Documentation Practices (GDP), and Quality Management Systems.
• Experience writing investigations, deviations, CAPAs, change controls, or similar quality documentation .
• Strong analytical, organizational, and problem-solving skills.
• Excellent written and verbal communication skills with exceptional attention to detail.
• Ability to manage multiple priorities while meeting deadlines.
• Proficiency with Microsoft Office Suite and electronic Quality Management Systems (eQMS).