QC Technical Writer

Hello,

I hope you're doing well.

My name is Soundarya, and I'm reaching out from Intellectt Inc. regarding an exciting contract opportunity for QC Technical Writer based in Salt Lake City, UT with one of our prestigious clients. I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at soundarya.kondra@intellectt.com

Job Title: QC Technical Writer
Location: Salt Lake City, UT
Work Arrangement: Onsite
Experience Level: 3 5 Years
Rate: $35/hr - $45/hr

Job Summary:
We are seeking an experienced QC Technical Writer to support Quality Control Chemistry and QC Microbiology documentation activities across clinical and commercial programs. This role will support technical documentation development, analytical data review, method transfer activities, validation documentation, and QC operational readiness initiatives.

The ideal candidate will combine strong technical writing skills with knowledge of QC laboratory operations, analytical testing processes, GMP documentation practices, and regulatory requirements. The QC Technical Writer will collaborate closely with QC scientists, subject matter experts (SMEs), and cross-functional teams to create accurate, compliant, and scientifically sound technical documents.

Key Responsibilities:

• Author, review, revise, and finalize technical documentation supporting QC Chemistry and QC Microbiology activities.
• Develop and update method transfer protocols, qualification protocols, validation documents, reports, and related technical documentation.
• Prepare and revise SOPs, controlled documents, analytical methods, and QC documentation.
• Support documentation activities related to BLA and regulatory submissions.
• Review analytical data, laboratory documentation, and technical source materials to create accurate reports and summaries.
• Draft technical reports using established templates, including periodic and operational reports.
• Collaborate with QC scientists and SMEs to gather technical information, resolve documentation gaps, and ensure scientific accuracy.
• Support analytical method transfer, technology transfer, method validation, and qualification activities.
• Prepare documentation packages supporting QC readiness, process validation, and manufacturing support activities.
• Ensure documentation aligns with GMP requirements, data integrity principles, internal procedures, and quality standards.
• Manage document lifecycle activities including formatting, review coordination, version control, and incorporation of feedback.
• Identify missing technical information and proactively work with stakeholders to complete documentation requirements.

Required Qualifications & Skills:

• Bachelor's degree in Chemistry, Biology, Microbiology, Pharmaceutical Sciences, Life Sciences, or a related scientific discipline.
• 5+ years of experience in a GMP-regulated pharmaceutical, biotechnology, or life sciences environment.
• Experience developing technical documentation within QC, analytical laboratory, or manufacturing environments.
• Experience authoring and revising SOPs, analytical methods, protocols, reports, and controlled GMP documents.
• Experience supporting regulatory documentation, BLA submissions, or other regulatory filing activities.
• Knowledge of GMP documentation practices and data integrity principles.
• Ability to interpret analytical data and technical laboratory documentation.
• Strong technical writing, editing, and communication skills.
• Ability to collaborate effectively with scientists, SMEs, and cross-functional teams.
• Ability to work onsite and support close collaboration with QC teams.

Benefits: Eligible employees may have access to benefits offered by Intellectt Inc. in accordance with the applicable benefit plans and eligibility requirements.

Equal Employment Opportunity: Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.

Thanks & Regards,
Soundarya
Technical Recruiter
Intellectt Inc
Soundarya@intellectt.com
Direct: 732 204 6899
Desk number: 732 412 6999 Ext: 247