Technical Writer

Job Title: Technical Writer
Job Location: Carlsbad, CA
Job Duration: 6 Months+
 
Shift Timing: Monday- Friday 8 am - 5 pm
Pay rate: $34/hr on w2.
 
Job Description: below
As a Technical Writer, you will be an important part of a cross-functional team tasked with aiding the site's operational team in problem-solving, process implementation, and investigative management, both independently and collaboratively. In this role, you will provide critical support to the manufacturing operational team by addressing daily quality issues and leading various initiatives, agendas, and projects.
 
Roles and Responsibilities:

• Develop precise and concise work instructions tailored to technical and scientific manufacturing procedures.
• Innovate and formulate procedures that align with product specifications and uphold thorough quality standards.
• Analyze historical production records and manufacturing documents to capture relevant data and insights into existing processes.
• Prepare investigation and root cause analysis reports per established quality standards.
• Develop close collaboration with manufacturing department personnel to resolve optimal document formats and identify methods, protocols, and standard methodologies to integrate into the instructions.
• Create and maintain documents using an electronic document management system.
• Ensure adherence to SKU data standards and supply chain prerequisites that impact SKU configuration.
• Collaborate with team members to efficiently distribute workloads, manage project progress, and conduct thorough reviews of colleagues' work to ensure accuracy.
• Own the design of validation documents and lead their implementation to completion.
• Lead initiatives for the implementation of Corrective and Preventive Actions (CAPA) to rectify deviations and address customer complaints.
• Apply internal software systems, including ERP, SKU Wizard, and Product Lifecycle Management, to lead the creation and modification of raw materials, sub-assemblies, and finished goods SKUs, ensuring accurate alignment with current manufacturing processes.

 
Education/Experience:

• Bachelor’s degree in sciences or engineering.
• 2+ years of experience developing and editing engineering documentation for production workflows and manufacturing records.
• Proven experience evaluating and editing SOP's and other documentation for accuracy and comprehension.
• Proven ability to write multiple Work Instructions and Validation Reports that align with product specifications and regulatory standards.
• 3+ years of experience in a manufacturing environment or similar role.
• 2+ years of experience in an ISO or cGMP-regulated manufacturing environment.
• 2+ years of experience in technical writing Proficiency with ERP systems and a basic understanding of cost accounting and standard manufacturing financials.
• Familiarity with Practical Process Improvement (PPI) Systems and tools (or equivalent Continuous Improvement and Lean Systems).
• Previous experience working with multifunctional teams on projects of varying complexity.
• Understanding of manufacturing processes and inter-departmental responsibilities.

 
Knowledge, Skills and Abilities

• Proficient in Microsoft Office Software, particularly Excel, Word, and PowerPoint Collaboration skills and the ability to effectively influence others.
• Excellent verbal and written communication skills.
• Thrives in a fast-paced work environment Consistently meticulous and precise in performing responsibilities.
• Maintains a positive demeanor towards the job and colleagues.
• Results driven and data-focused.
• Proficient in understanding manufacturing operational flows, including but not limited to Formulations, Protein Purification, Antibody Manufacturing, Filling, and Assembly/Packaging Possesses robust project management skills.
• Proactively anticipates needs and identifies solutions to problems.