Technical Writer Data Collection Biopharma
Kinetic Personnel Group, Inc, Irvine, CA, United States
We are seeking a detail-oriented Technical Writer to support deviation writing, data collection, and documentation processes within a biopharmaceutical environment. This role plays a critical part in ensuring accurate, compliant, and timely documentation to support quality systems and regulatory requirements.
Key Responsibilities
Author, review, and edit deviation reports, ensuring clarity, accuracy, and compliance with internal procedures and regulatory standards
Collaborate cross-functionally with Quality, Manufacturing, and Engineering teams to gather required data for investigations
Support root cause analysis documentation and ensure proper alignment with collected data
Organize and compile data from multiple sources to support deviation records and trending activitiesEnsure consistency and quality of technical documentation across systems
Assist with CAPA (Corrective and Preventive Action) documentation as needed
Maintain documentation in electronic quality management systems (eQMS)
Track and manage documentation timelines to meet internal and regulatory deadlines
Required Qualifications
Bachelor’s degree in Life Sciences, Engineering, Technical Writing, or related field
5+ years of experience in technical writing within biopharma, pharmaceutical, or regulated industries
Experience supporting deviation investigations and quality documentation
Strong understanding of GMP (Good Manufacturing Practices) environments
Excellent written and verbal communication skills
Ability to translate complex technical data into clear, concise documentation
Strong attention to detail and organizational skills
Preferred Qualifications
Familiarity with regulatory expectations (FDA, EMA)
Experience supporting audits or inspections
Knowledge of data trending and reporting tools
Analytical thinking and problem-solving
Cross-functional collaboration
Time management and ability to meet deadlines
High level of accuracy and compliance focus
Why Join Us
Opportunity to work in a fast-paced, highly regulated biopharma environment
Contribute directly to product quality and patient safety
Collaborative and innovative team culture
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Key Responsibilities
Author, review, and edit deviation reports, ensuring clarity, accuracy, and compliance with internal procedures and regulatory standards
Collaborate cross-functionally with Quality, Manufacturing, and Engineering teams to gather required data for investigations
Support root cause analysis documentation and ensure proper alignment with collected data
Organize and compile data from multiple sources to support deviation records and trending activitiesEnsure consistency and quality of technical documentation across systems
Assist with CAPA (Corrective and Preventive Action) documentation as needed
Maintain documentation in electronic quality management systems (eQMS)
Track and manage documentation timelines to meet internal and regulatory deadlines
Required Qualifications
Bachelor’s degree in Life Sciences, Engineering, Technical Writing, or related field
5+ years of experience in technical writing within biopharma, pharmaceutical, or regulated industries
Experience supporting deviation investigations and quality documentation
Strong understanding of GMP (Good Manufacturing Practices) environments
Excellent written and verbal communication skills
Ability to translate complex technical data into clear, concise documentation
Strong attention to detail and organizational skills
Preferred Qualifications
Familiarity with regulatory expectations (FDA, EMA)
Experience supporting audits or inspections
Knowledge of data trending and reporting tools
Analytical thinking and problem-solving
Cross-functional collaboration
Time management and ability to meet deadlines
High level of accuracy and compliance focus
Why Join Us
Opportunity to work in a fast-paced, highly regulated biopharma environment
Contribute directly to product quality and patient safety
Collaborative and innovative team culture
#J-18808-Ljbffr