Technical Writer

Indotronix Avani Group; Carlsbad (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Indotronix Avani Group is seeking a Technical Writer to join the Manufacturing Sciences team in Carlsbad, CA. You will support site operations by solving problems, implementing processes, and managing investigations with cross-functional teams.

You will prepare investigation reports, analyze production records, and collaborate on optimal documentation formats while ensuring quality and compliance across systems like ERP, EQMS, and DMS.

Qualifications

• Bachelor’s degree in Science or Engineering required.
• Experience reviewing batch records for accuracy.
• Familiarity with Practical Process Improvement (PPI) or Lean.
• Cross-functional project experience.

Responsibilities

• Prepare investigation reports and root cause analyses in accordance with quality standards.
• Analyze historical production records and manufacturing documentation to extract data and insights.
• Collaborate with manufacturing personnel to determine optimal document formats and procedures.
• Author thorough, accurate, compliant investigation documentation.
• Utilize ERP, EQMS, and DMS to gather and analyze information for investigations.
• Meet weekly targets for investigation submissions with high accuracy.

Skills

Excel

Written communication

Attention to detail

Collaboration

Data-driven

Time management

Problem-solving

Project management

Education

Bachelor’s degree in Science or Engineering

Tools

ERP

EQMS

DMS

Job description

• As a Technical Writer joining the Manufacturing Sciences team, you will play a key role on a cross-functional team supporting site operations in problem-solving, process implementation, and investigative management.
• Working both independently and collaboratively, you will provide critical support to manufacturing operations by addressing quality issues and contributing to key initiatives, operational agendas, and cross-functional projects.

What You Will Do:

• Prepare investigation reports and root cause analyses in accordance with established quality standards.
• Analyze historical production records and manufacturing documentation to extract relevant data and insights into current processes.
• Collaborate closely with manufacturing personnel to determine optimal document formats and identify appropriate methods, protocols, and best practices to incorporate into procedural instructions.
• Author thorough, accurate, and compliant investigation documentation while maintaining strict adherence to quality documentation standards.
• Utilize internal software systems, including ERP, Enterprise Quality Management Systems, and Document Management Systems, to gather and analyze information for investigations.
• Meet weekly targets for investigation submissions while maintaining high standards of accuracy and quality.

Education:

• Bachelor’s degree in Science or Engineering.

Experience:

• Experience reviewing and evaluating manufacturing batch records and related documentation for accuracy and completeness.
• Familiarity with Practical Process Improvement (PPI) systems and tools, or equivalent Continuous Improvement/Lean methodologies.
• Experience collaborating with cross-functional teams on projects of varying complexity.
• Solid understanding of manufacturing processes and interdepartmental workflows.

Knowledge, Skills, and Abilities:

• Proficiency in Microsoft Office applications, particularly Excel.
• Excellent written and verbal communication skills.
• Ability to thrive in a fast-paced, dynamic environment.
• Highly detail-oriented with strong accuracy and precision in documentation.
• Positive, professional attitude and strong collaborative mindset.
• Results-driven and data-focused approach to work.
• Understanding of manufacturing operational flows, including Antibody Purification, Conjugation, and immunoassay QC assays.
• Strong project management and time management skills.
• Proactive problem-solving mindset with the ability to anticipate needs and identify effective solutions.