QC Technical Writer

Hello,

I hope you're doing well.

My name is Rudra , and I'm reaching out from Intellectt Inc . regarding an exciting contract opportunity for a 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 View email address on us.fitly.work

Job Title: QC Technical Writer



Location: Salt Lake City, UT



Work Arrangement: Onsite



Experience Level: 3-5 Years



Pay Rate: $35-$40/hr

Skills: QC TECHNICAL WRITING, GMP DOCUMENTATION, PHARMACEUTICAL TECHNICAL WRITING, REGULATORY WRITING, QC CHEMISTRY, QC MICROBIOLOGY, ELISA, STERILITY TESTING

Job Description:

Author, revise, and finalize technical documentation supporting QC Chemistry and QC Microbiology, including method transfer, qualification, validation, and readiness activities
Develop and revise method transfer protocols, qualification protocols, reports, and associated technical documentation
Support the drafting and revision of analytical methods and related QC documentation
Develop and update SOPs and other controlled documents, with a high volume of SOP writing and revision expected
Support documentation required for BLA and regulatory submissions, including translating complex analytical information into clear, scientifically accurate written content
Review analytical data, laboratory documentation, and technical source materials to support accurate reports and other QC deliverables
Draft and revise reports using established templates, including periodic and quarterly reports
Collaborate directly with QC scientists and SMEs to understand analytical activities, resolve gaps or inconsistencies, and ensure technical accuracy
Support analytical method transfers and technology transfer activities, including documentation required for transfer readiness
Assist with documentation packages supporting method validation, qualification, PPQ readiness, and overall QC operational readiness
Ensure documentation is scientifically accurate, clear, consistent, and aligned with GMP, data integrity, and internal quality requirements
Manage document lifecycle activities including formatting, review coordination, revisions, version control, and incorporation of SME feedback
Work closely with the QC team onsite to facilitate efficient communication, obtain technical input, and reduce the documentation burden on QC scientists
Identify missing or unclear technical information and proactively work with SMEs to obtain the information needed to complete high-quality documentation

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,

Kunnath Rudra Prasad
Technical Recruiter
Intellectt Inc


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