Technical Writer 1

Technical Writer I - Manufacturing SciencesWe are seeking a detail-oriented Technical Writer I to join our Manufacturing Sciences team. In this role, you will support manufacturing operations by conducting investigations, performing root cause analysis, reviewing production documentation, and authoring compliant reports in a regulated manufacturing environment. This position is ideal for candidates with a Science or Engineering degree and experience working with GMP documentation, manufacturing records, quality systems, and cross-functional teams.Key ResponsibilitiesAuthor and maintain investigation reports, deviation documentation, and root cause analyses in compliance with quality and regulatory standards.Review manufacturing batch records, production records, and process documentation to identify trends, discrepancies, and opportunities for improvement.Analyze historical manufacturing data and documentation to support investigations and operational decisions.Partner with manufacturing, quality, and technical teams to develop clear and effective procedures, work instructions, and documentation.Utilize ERP, Quality Management Systems (QMS), and Document Management Systems (DMS) to support investigations and documentation activities.Ensure timely completion of investigations while maintaining accuracy, compliance, and documentation quality.Support process improvement initiatives and continuous improvement projects.Required QualificationsBachelor's Degree in Science, Engineering, Biology, Chemistry, Biochemistry, Biotechnology, or related STEM field.Experience reviewing manufacturing batch records, GMP documentation, or quality records.Knowledge of GMP-regulated manufacturing environments.Experience performing investigations and root cause analysis.Familiarity with Continuous Improvement, Lean, PPI, Six Sigma, or equivalent methodologies.Strong Microsoft Office skills, especially Excel.Excellent written, verbal, and technical communication skills.Strong organizational, project management, and time management abilities.Ability to work effectively in a fast-paced, collaborative environment.Preferred QualificationsExperience with ERP systems, QMS, and electronic document management systems.Understanding of biopharmaceutical or diagnostic manufacturing processes.Knowledge of: Antibody Purification, Conjugation Processes, Immunoassay Quality Control (QC) Assays.Experience supporting manufacturing investigations and quality-related initiatives.Job Type & Location: This is a Contract position based out of Carlsbad, CA.Pay and Benefits: The pay range for this position is $33.00 - $33.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision; Critical Illness, Accident, and Hospital; 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available; Life Insurance (Voluntary Life & AD&D for the employee and dependents); Short and long-term disability; Health Spending Account (HSA); Transportation benefits; Employee Assistance Program; Time Off/Leave (PTO, Vacation or Sick Leave).Workplace Type: This is a fully onsite position in Carlsbad, CA.Application Deadline: This position is anticipated to close on Sep 17, 2026.