Technical Writer

About This Role

This role involves authoring and reviewing Analytical Test Methods to commercialize procedures for the QC testing area. The individual will also contribute to regulatory submissions and ensure documentation complies with cGMP standards.

Responsibilities

• Author and critically review technical documents, including Regulatory Filing sections and Analytical Test Methods
• Author and review documentation compliant with current Good Manufacturing Practices (cGMP), including Second Person Review or Second Scientist Review
• Participate in group initiatives related to document standards, template development, internal processes, and other aspects of document management
• Collaborate closely with key stakeholders

Requirements

• BS/BA in life sciences/engineering
• At least 2 years working experience in a cGMP laboratory environment
• Experience in the biopharmaceutical manufacturing industry, such as in biologics or vaccines commercialization, technical operations, or quality control
• Strong oral and written communication skills
• Ability to work independently and within cross-functional teams
• Maintain a proactive and service-oriented mindset
• Experience with MS Office and document repository systems

Qualifications

• BS/BA in life sciences/engineering
• At least 2 years working experience in a cGMP laboratory environment.

Nice to Have

• Master's degree/PHD

Skills

* Required skills