Technical Writer Jobs

About The Position

Requirements

• Expertise in technical writing, including reports and controlled procedures.
• Experience conducting, auditing, and supporting GxP laboratory documentation, protocols, and testing.
• Experience leading process-improvement efforts in laboratory, quality, or compliance settings.
• Experience training staff in procedures, assays, and laboratory systems.
• Experience operating in a GxP laboratory environment.
• Strong critical-thinking, troubleshooting, verbal-communication, and written-communication skills.
• Ability to follow procedures and thoroughly document laboratory work.
• Ability to work independently with limited supervision and meet project timelines.
• Strong attention to detail and ability to manage multiple priorities.
• Adherence to applicable safety procedures in a BSL-2 laboratory.

Nice To Haves

• Experience with a GxP bioanalytical or clinical testing laboratory.
• Experience with Laboratory Information Management Systems, electronic laboratory notebooks, and other scientific applications.

Responsibilities

• Lead Compliance team technical-writing activities, including procedures, process flows, regulatory and audit responses, and reports concerning trending, deviations, investigations, and validation.
• Lead quality-process improvements to strengthen GxP testing operations, systems, procedures, and documentation practices.
• Conduct detailed laboratory data and in-lab process reviews to support the integrity, accuracy, completeness, and quality of GxP data.
• Collaborate with Quality Assurance to maintain alignment with company policies and applicable federal regulations and support inspection readiness.
• Participate in regulatory inspections and internal Quality Assurance audits, including preparation and follow-up.
• Monitor laboratory operations and quality metrics, identify trends, and drive process and procedural improvements.
• Evaluate system data integrity and end-to-end data flows, identify enhancement or modernization opportunities, and participate in computer and laboratory system validation.
• Develop or update procedures supporting documentation reviews and process reviews.
• Lead training and coach department staff on SOP adherence, documentation requirements, procedures, assays, and laboratory systems.
• Participate in or lead initiatives that strengthen quality operations and support setup of the new facility and laboratories.

Benefits

• Comprehensive medical coverage
• Dental coverage options
• Vision coverage options
• Life insurance
• Disability insurance
• 401(k) with company match
• Paid vacation
• Paid holidays