Technical Writer

Reference #: 609def4e-aa93-45e7-9463-5cc564e6bfa8

Summary

• The candidate may also author and review documents supporting regulatory submissions working closely with regulatory groups.
• The successful candidate must function well and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment.

Primary Responsibilities:

• Authoring and critically reviewing technical documents including Regulatory Filing sections and Analytical Test Methods.
• Authoring and reviewing 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.

Education:

• Minimum qualification- BS/BA in life sciences/engineering is required
• Master's degree/PHD preferred

Required Experience and Skills:

• 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.
• Work independently and within cross-functional teams.
• Maintain a proactive and service-oriented mindset.
• Experience with MS Office and document repository systems.

Preferred Experience and Skills:

• Experience with analytical method validation and transfer according to ICH and USP guidelines.
• Experience with laboratory data management systems

Software skills: MS office suite

Personality:

• Detail oriented
• Excellent writing skills
• Collaborative
• Good communication and interpersonal skills.

SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at nahr@spectraforce.com if you require reasonable accommodation.