Technical Writer (Batch Record Review)

VARITE • Carlsbad, CA

3d • Onsite

About The Position

VARITE is looking for a qualified Technical Writer to join the Manufacturing Sciences team in Carlsbad, CA. This role is crucial for supporting site operations in problem-solving, process implementation, and investigative management. The Technical Writer will work both independently and collaboratively to provide critical support to manufacturing operations by addressing quality issues and contributing to key initiatives, operational agendas, and cross-functional projects.

Requirements

• Bachelor’s degree in Science or Engineering.
• 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.
• 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.

Responsibilities

• 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.

Benefits

• Health Insurance: Medical, dental, and vision coverage
• Retirement Plans: Participation in a company-sponsored retirement savings plan.
• Legal Service Plans: Offering access to attorneys for legal advice and representation.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level