Technical Writer

** Technical Writer - Manufacturing Sciences*
* *
* Location:

** Carlsbad, CA

** Pay Rate:**  $33.00 per hour

** Position Type:
** Full-Time

** Position Overview*
* We are seeking a detail-oriented  
** Technical Writer
** to support manufacturing operations within a regulated life sciences environment. This position will work closely with Manufacturing Sciences, Quality, and cross-functional teams to support investigations, process improvements, documentation initiatives, and operational projects.

The ideal candidate will have strong technical writing skills, experience working with manufacturing documentation, and the ability to analyze complex information and translate it into clear, accurate, and compliant documentation.

** Key Responsibilities*
* + Prepare detailed investigation reports and root cause analyses in accordance with established quality standards.

+ Review historical production records, batch documentation, and manufacturing records to identify relevant information and trends.

+ Analyze manufacturing documentation to support investigations and identify potential process issues.

+ Collaborate with manufacturing personnel and subject matter experts to determine appropriate document formats, procedures, protocols, and best practices.

+ Write clear, accurate, thorough, and compliant investigation documentation.

+ Ensure all documentation meets applicable quality and documentation standards.

+ Use enterprise systems, including ERP, quality management, and document management platforms, to gather and analyze information.

+ Support investigation activities by collecting, organizing, and evaluating data from multiple sources.

+ Meet established weekly investigation and documentation deadlines while maintaining a high level of accuracy.

+ Participate in cross-functional projects and operational improvement initiatives.

+ Assist with identifying opportunities to improve processes, documentation, and manufacturing workflows.

** Required Qualifications*
* +  
** Bachelor's degree in Science or Engineering.*
* + Experience reviewing and evaluating  
** manufacturing batch records and related documentation
** for accuracy and completeness.

+ Experience preparing technical, quality, or investigative documentation.

+ Understanding of manufacturing processes and cross-functional operational workflows.

+ Experience working with teams across Manufacturing, Quality, Engineering, or other technical functions.

+ Strong analytical and problem-solving skills.

+ Excellent written and verbal communication abilities.

+ Exceptional attention to detail and accuracy.

** Preferred Experience*
* + Familiarity with  
** Lean, Continuous Improvement, or Practical Process Improvement (PPI)
** methodologies.

+ Experience supporting manufacturing investigations or root cause analysis.

+ Experience working in a pharmaceutical, biotechnology, medical device, or other regulated manufacturing environment.

+ Familiarity with manufacturing processes such as  
** antibody purification, conjugation, or immunoassay quality control testing** .

+ Experience using ERP, electronic quality management, or document management systems.

** Knowledge, Skills & Abilities*
* + Proficiency with  
** Microsoft Office, particularly Excel** .

+ Strong technical writing and documentation skills.

+ Ability to analyze and interpret manufacturing data and historical records.

+ Excellent organizational and project management skills.

+ Strong time management and ability to meet recurring deadlines.

+ Ability to manage multiple priorities in a fast-paced environment.

+ Proactive approach to identifying problems and developing practical solutions.

+ Ability to work independently while collaborating effectively with cross-functional teams.

+ Professional, positive, and results-oriented approach.

+ Strong commitment to documentation accuracy, quality, and compliance.

** Work Environment*
* This position supports manufacturing operations in a regulated environment and requires close collaboration with technical, manufacturing, and quality personnel. The successful candidate must be comfortable working with detailed documentation, electronic systems, production records, and time-sensitive investigations.

** Compensation*
* **$33.00 per hour*
* ** Pay Details:**  $33.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs.  In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

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The Company will consider qualified…